Skip to content

Pb Diagnostic Systems, Inc.

United StatesFDA applicant, unverified

Devices
35

Catalogue35

Newest first, rows 1-35 of 35

Search and filter all 35 devices
Skip device list

  • Opus Napa Ref K934705

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

  • Opus Tsh Test System Ref K902333

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

  • Opus Digitoxin Ref K935229

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

  • Opus Immunoassay System Ref K894159

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

  • Opus FT4 Test System Ref K940507

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

  • Opus Phenobarbital Test System Ref K896861

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

  • Opus T4 Test System Ref K897193

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

  • Opus Myoglobin Test System Ref K915850

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

  • Opus(R) Plus Analyzer Ref K913295

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

  • Opus Procainamide Test System Ref K934762

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

  • Opus Tm T-Uptake Test System Ref K902797

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

  • Opus(R) Total B-Hcg Test System Ref K932279

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

  • Behring Polaroid Opus Theophylline Ref K885044

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

  • Opus Gentamicin Ref K905721

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

  • Opus(R) Vancomycin Ref K924957

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

  • Opus Ferritin Test System Ref K915838

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

  • Opus(R) Prolactin Test System Ref K913280

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

  • Modified Opus Valproic Acid Test System Ref K901538

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

  • Opus(R) Lh Test System Ref K913938

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

  • Opus Cmv Test System Ref K905257

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

  • Opus Estradiol Ref K933066

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

  • Opus(R) Tobramycin Ref K911940

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

  • Opus Cmv-G Ref K933389

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

  • Opus Fsh Ref K911409

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

  • Opus T3 Test System Ref K905410

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

  • Modified Opus Phenobarbital Test System Ref K901537

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

  • Opus(R) Ck-Mb Ref K924429

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

  • Opus(R) Rozo Ref K911834

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

  • Opus Total Ck Ref K933675

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

  • Opus Phenytoin Test System Ref K896868

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

  • Opus(Tm) Digoxin Test System Ref K901547

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

  • Opus (Tm) Hcg Ref K901935

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

  • Opus Carbamazepine Test System Ref K896860

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

  • Opus Magnum Analyzer Ref K926131

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

  • Opus(R) Serology Controls, Modification Ref K934137

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

Rows 1-35 of 35

Frequently asked questions

How many devices does Pb Diagnostic Systems, Inc. have in the registry?

The registry currently lists 35 devices for Pb Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pb Diagnostic Systems, Inc.'s devices?

Among its 35 most recently registered devices, Pb Diagnostic Systems, Inc. has devices listed in FDA 510(k) (35 devices).

What risk classes do Pb Diagnostic Systems, Inc.'s devices fall under?

Among its 35 most recently registered devices, the classes recorded for Pb Diagnostic Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Pb Diagnostic Systems, Inc. in the registry?

The most recently registered devices listed for Pb Diagnostic Systems, Inc. include OPUS NAPA, OPUS TSH TEST SYSTEM, OPUS DIGITOXIN and OPUS IMMUNOASSAY SYSTEM.

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