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FDA 510(k)

HISTOSET IMMUNOPEROXIDASE TISSURE KIT

K-Number: K820390 · 1982-04-14

ApplicantImmulok, Inc.
Decision Date1982-04-14
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HISTOSET IMMUNOPEROXIDASE TISSURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820390. The device is classified under product code LKH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOSET IMMUNOPEROXIDASE TISSURE KIT?

HISTOSET IMMUNOPEROXIDASE TISSURE KIT is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Immulok, Inc.. The 510(k) number is K820390.

When did HISTOSET IMMUNOPEROXIDASE TISSURE KIT receive FDA 510(k) clearance?

HISTOSET IMMUNOPEROXIDASE TISSURE KIT received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820390.

Who is the listed applicant for HISTOSET IMMUNOPEROXIDASE TISSURE KIT?

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 IMMUNOPEROXIDASE TISSURE KIT?

The FDA product code for HISTOSET IMMUNOPEROXIDASE TISSURE KIT is LKH.

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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: LKH)

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.

K910644IPAZYME (TM) CHLAMYDIA IGG-IGASavyon Diagnostics , Ltd.K901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)Savyon Diagnostics , Ltd.K882674IMMU-MARK(TM) CHLAMYDIA IGG/IGA KITIcn ImmunobiologicalsK893669CELLMATICS SHLAMYDIA DETECTION SYSTEMDifco Laboratories, Inc.K852869SELECTICULT-CHLAMYDIAScott Laboratories, Inc.K842151CHLAMYDIAE IMMUNOPEROXIDASE TEST KITBartels Immunodiagnostic Supplies, 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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