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FDA 510(k)

HISTOSET IMMUNOPEROFIDASE TISSUE

K-Number: K821411 · 1982-06-25

ApplicantImmulok, Inc.
Decision Date1982-06-25
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HISTOSET IMMUNOPEROFIDASE TISSUE is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821411. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOSET IMMUNOPEROFIDASE TISSUE?

HISTOSET IMMUNOPEROFIDASE TISSUE is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Immulok, Inc.. The 510(k) number is K821411.

When did HISTOSET IMMUNOPEROFIDASE TISSUE receive FDA 510(k) clearance?

HISTOSET IMMUNOPEROFIDASE TISSUE received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821411.

Who is the listed applicant for HISTOSET IMMUNOPEROFIDASE TISSUE?

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

What is the FDA product code for HISTOSET IMMUNOPEROFIDASE TISSUE?

The FDA product code for HISTOSET IMMUNOPEROFIDASE TISSUE is GQL.

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Other records listing Immulok, 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.

K830971HERPES SIMPLEX VIRUS TYPING REAGENTSK830342CULUTURE SET CHLAMYDIA ISOLATION ANDK830250CVT VIRAL TRANSPORTSK823304RIASET PROLACTIN RIA KITK822785FLUOROSET IMMUNOFLUORESCENT ANTIBODYK823055FLOUROSET IMMUNOFLUORESCENT ANTIBODY

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Related Devices (Code: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, 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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