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FDA 510(k)

THROMBOQUIK THROMBIN REAGENT PROD. #3551

K-Number: K800926 · 1980-05-08

ApplicantGeneral Diagnostics
Decision Date1980-05-08
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOQUIK THROMBIN REAGENT PROD. #3551 is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800926. 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 THROMBOQUIK THROMBIN REAGENT PROD. #3551?

THROMBOQUIK THROMBIN REAGENT PROD. #3551 is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is General Diagnostics. The 510(k) number is K800926.

When did THROMBOQUIK THROMBIN REAGENT PROD. #3551 receive FDA 510(k) clearance?

THROMBOQUIK THROMBIN REAGENT PROD. #3551 received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800926.

Who is the listed applicant for THROMBOQUIK THROMBIN REAGENT PROD. #3551?

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

What is the FDA product code for THROMBOQUIK THROMBIN REAGENT PROD. #3551?

The FDA product code for THROMBOQUIK THROMBIN REAGENT PROD. #3551 is GJA.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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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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