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FDA 510(k)

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

K-Number: K023991 · 2003-04-28

ApplicantPrecision Biologic
Decision Date2003-04-28
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 2003-04-28 under 510(k) number K023991. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50?

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Precision Biologic. The 510(k) number is K023991.

When did CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 receive FDA 510(k) clearance?

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 received FDA 510(k) clearance on 2003-04-28, under 510(k) number K023991.

Who is the listed applicant for CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50?

The FDA 510(k) record lists Precision Biologic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50?

The FDA product code for CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 is JBQ.

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Other records listing Precision Biologic as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193556Cryocheck Hex LAK193204Cryocheck Chromogenic Factor VIIIK032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLK023990CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10K990580CRYOCHECK LA SURE, MODEL SUR25-10

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Related Devices (Code: JBQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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