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Streck Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
70

What Streck Laboratories, Inc. makes

Streck Laboratories, Inc. manufactures diagnostic control materials and calibration devices for hematology analyzers, including platelet and reticulocyte controls (e.g., PARA 12 PLUS, RETIC CHEX LINEARITY), human platelet calibrators (PLATELET-CHEX-HUMAN), and differential controls (PARA 5 DIFF). Their portfolio also includes chemistry controls (CHEM-CHEX STAT), CD4/CD3/CD8 calibration and control products (CD-CHEX, CD-CHEX CD4 LOW), and hematology calibration standards (PC-CALIBRATOR). Additional offerings cover linearity verification (PARA 12 PLUS RETICS) and general hematology controls (HEMATO-CHEX).

These products are regulated under the FDA’s 510(k) pathway, with device classifications ranging from Class I to Class II. The company’s controls and calibrators are listed in the FDA’s 510(k) registry, ensuring compliance with U.S. medical device regulations. Streck Laboratories, Inc. is headquartered in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue70

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  • Cell-Chex Rbc Ref K811741

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

  • Chem-Chex Bilirubin Ref K902867

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

  • Sugar-Chex Ref K851042

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

  • Cd-Chex Cd 34 Ref K993126

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

  • Chem Chex Theophylline Control Ref K920223

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

  • Platelet Kit Ref K772105

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

  • Retic-Chex Ref K905524

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

  • Stak-Chex Ref K911582

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

  • Sugar Chex One Ref K001443

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

  • Reflo-Chex, A Cholesterol Reference Control Ref K873105

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

  • Para-8 Ref K791228

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

  • Kryorack/4 Ref K780757

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

  • Hepaquant Ref K813011

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

  • Platelet Counting Kit Ref K802636

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

  • Sf-Check Ref K952245

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

  • Para Check (Aka Eight Check-C) Ref K852992

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

  • Para 12 Ref K823498

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

  • Ret-Check Ref K900484

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

  • Chem-Chex Ref K913687

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

  • Cd-Chex + Rbc Ref K960894

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

Rows 51-70 of 70

Showing 51-70 of 70