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FDA 510(k)

FIBRI QUIK

K-Number: K802117 · 1980-09-26

ApplicantGeneral Diagnostics
Decision Date1980-09-26
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRI QUIK is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802117. 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 FIBRI QUIK?

FIBRI QUIK is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is General Diagnostics. The 510(k) number is K802117.

When did FIBRI QUIK receive FDA 510(k) clearance?

FIBRI QUIK received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802117.

Who is the listed applicant for FIBRI QUIK?

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 FIBRI QUIK?

The FDA product code for FIBRI QUIK 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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