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FDA 510(k)

THROMBINEX BOVINE THROMBIN

K-Number: K845000 · 1985-03-26

ApplicantBio/Data Corp.
Decision Date1985-03-26
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBINEX BOVINE THROMBIN is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1985-03-26 under 510(k) number K845000. The device is classified under product code GJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBINEX BOVINE THROMBIN?

THROMBINEX BOVINE THROMBIN is a medical device that received FDA 510(k) clearance on 1985-03-26. The listed applicant is Bio/Data Corp.. The 510(k) number is K845000.

When did THROMBINEX BOVINE THROMBIN receive FDA 510(k) clearance?

THROMBINEX BOVINE THROMBIN received FDA 510(k) clearance on 1985-03-26, under 510(k) number K845000.

Who is the listed applicant for THROMBINEX BOVINE THROMBIN?

The FDA 510(k) record lists Bio/Data Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THROMBINEX BOVINE THROMBIN?

The FDA product code for THROMBINEX BOVINE THROMBIN is GJA.

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Other records listing Bio/Data Corp. 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.

K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CK943153MICROSAMPLE COAGULATION ANALYZERK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK881150KINETIC FIBRINOGEN ASSAYK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA

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Related Devices (Code: GJA)

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.

K050817T-TEKR2 Diagnostics, Inc.K982209ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Sigma Diagnostics, Inc.K970645BC THROMBIN REAGENTBehring Diagnostics, Inc.K925493BIOMERIEUX HEMOLAB THROMBICALCI-TESTBiomerieux Vitek, Inc.K930157TEST THROMBINBehring Diagnostics, Inc.K923220THROMBIN CLOT TIME TEST PROCEDUREMedical Laboratory Automation Systems, Inc.

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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