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Harleco

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Devices
116

Catalogue116

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  • Ultra Zyme Plus Ck-1 #64978, 65027 & 28 Ref K812593

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrachem Phosphorus, 64973 Ref K772156

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ultrachem Total Protein, #64974 Ref K772155

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Plus Alp Ref K770870

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultra Zyme Plus Gpt, #64956, 65035 & 36 Ref K812591

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ultrazyme Alkaline Phosphatase Ref K760024

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrachem Ca, Item #64975 Ref K813040

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Total Protein Set, Item No. 64010 Ref K771926

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Plus Gpt Ref K770882

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ck-1 Ultrazyme Plus Ref K771389

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Dsp - Stain Pack Ref K760027

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ultrachem Calcium Ref K770817

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Krystalonr Liq. Mounting Med.&Coverslip Ref K771925

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Cardiozyme Plus Ck-Mb Item #65045 (G) Ref K811575

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Auto Total Protein For Analyzer Ref K770887

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Unipak Uric Acid Ref K771088

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Histochemical Afb Demonstration Ref K771390

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Qualitrol #65057 Ref K810725

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Cardio Zyme Plus Ck-Mb #65045 Ref K803168

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Stain Set, Histochemical Afb Ref K760484

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Saline, Isotonic Buffered, Azide-Free Ref K760129

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Isotonic Buffered Saline Ref K780830

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Unipak Glucose Ref K771091

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Cardiozyme Plus Ck-Total Item #65046 Ref K811574

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gemsaec Appli. For Ultrazyme Plus Alp Ref K772032

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Unipak Cholesterol Ref K771093

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Creatinine Urine Appli.-#32308 Ref K772107

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Clinicard Ck-Ii Ref K772258

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Plus, Ldh Ref K770818

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Auto-Calcium Reag For Gilford 3400E Anal Ref K761029

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Plus Gamma Gt(65055-65056) Ref K820233

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ultrachem Gluc-Dh, Item No. 65048 Ref K811202

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultra Zyme Plus Got #64953, 65033 & 34 Ref K812592

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Clinicard Creatinine Chemistry Ref K771773

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Unipak Bun Ref K771087

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Amylase Ref K760026

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrachem E-Glu, 300 Series Centrifuchem Ref K780515

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Unipak Hemoglobin Ref K771090

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultra Zyme Plus Ldh #64950, 65038 & 39 Ref K812590

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Plus Alp Ref K780095

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrachem E-Glu, Manual Determ. Ref K780065

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Clinicard Phosphorus Ref K760030

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Iron Binding Capacity Chemistry Ref K780094

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Auto-Enzymatic Glucose For Analyzer Ref K770886

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultra Chem E-Trig #65024 Ref K812589

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Manuel Bilirubin Reagent Set Ref K770121

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ultrazyme Plus Gpt Ref K780102

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ultrazyme Plus Gt Ref K770815

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Ultrazyme Plus Got Ref K770883

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Ultrachem Crea Item #64972 Ref K813043

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 116

Showing 1-50 of 116

Frequently asked questions

How many devices does Harleco have in the registry?

The registry currently lists 116 devices for Harleco. Devices recorded under merged duplicate company entries are counted once.

Which registries list Harleco's devices?

Among its 50 most recently registered devices, Harleco has devices listed in FDA 510(k) (50 devices).

What risk classes do Harleco's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Harleco's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Harleco in the registry?

The most recently registered devices listed for Harleco include ULTRA ZYME PLUS CK-1 #64978, 65027 & 28, ULTRACHEM PHOSPHORUS, 64973, ULTRACHEM TOTAL PROTEIN, #64974 and ULTRAZYME PLUS ALP.

Generated automatically from registry data and not verified by a human reviewer.