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FDA 510(k)

ANTINUCLEAR ANTIBODY SCREEN FLOURESC

K-Number: K821576 · 1982-06-10

ApplicantImmuno-Products Industries
Decision Date1982-06-10
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY SCREEN FLOURESC is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Products Industries. It received FDA 510(k) clearance on 1982-06-10 under 510(k) number K821576. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTINUCLEAR ANTIBODY SCREEN FLOURESC?

ANTINUCLEAR ANTIBODY SCREEN FLOURESC is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Immuno-Products Industries. The 510(k) number is K821576.

When did ANTINUCLEAR ANTIBODY SCREEN FLOURESC receive FDA 510(k) clearance?

ANTINUCLEAR ANTIBODY SCREEN FLOURESC received FDA 510(k) clearance on 1982-06-10, under 510(k) number K821576.

Who is the listed applicant for ANTINUCLEAR ANTIBODY SCREEN FLOURESC?

The FDA 510(k) record lists Immuno-Products Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTINUCLEAR ANTIBODY SCREEN FLOURESC?

The FDA product code for ANTINUCLEAR ANTIBODY SCREEN FLOURESC is DBL.

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Other records listing Immuno-Products Industries 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.

K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDK852230ANA/LITE-RL TEST SYSTEMK852231ANA/LITE-HEP-2 TEST SYSTEMK843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK830652ANTI N DNA-HCP

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Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.

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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