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FDA 510(k)

BOVINE THROMBIN, HUMAN THROMBIN

K-Number: K841956 · 1984-07-19

ApplicantHaemachem, Inc.
Decision Date1984-07-19
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BOVINE THROMBIN, HUMAN THROMBIN is the device name listed in this FDA 510(k) record. The listed applicant is Haemachem, Inc.. It received FDA 510(k) clearance on 1984-07-19 under 510(k) number K841956. 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 BOVINE THROMBIN, HUMAN THROMBIN?

BOVINE THROMBIN, HUMAN THROMBIN is a medical device that received FDA 510(k) clearance on 1984-07-19. The listed applicant is Haemachem, Inc.. The 510(k) number is K841956.

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

BOVINE THROMBIN, HUMAN THROMBIN received FDA 510(k) clearance on 1984-07-19, under 510(k) number K841956.

Who is the listed applicant for BOVINE THROMBIN, HUMAN THROMBIN?

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

What is the FDA product code for BOVINE THROMBIN, HUMAN THROMBIN?

The FDA product code for BOVINE THROMBIN, HUMAN THROMBIN is GJA.

Related Clinical Trials

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Other records listing Haemachem, Inc. 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.

K903874FIBRINOTEST(TM) - FIBRINOGEN ASSAYK853239HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAYK841957BOVINE FACTOR XA-HUMAN FACTOR XA

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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