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FDA 510(k)

ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB

K-Number: K831054 · 1983-04-27

ApplicantImmuno-Products Industries
Decision Date1983-04-27
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB 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 1983-04-27 under 510(k) number K831054. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB?

ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Immuno-Products Industries. The 510(k) number is K831054.

When did ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB receive FDA 510(k) clearance?

ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB received FDA 510(k) clearance on 1983-04-27, under 510(k) number K831054.

Who is the listed applicant for ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB?

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 TISSUE CULTURE SUB?

The FDA product code for ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB is DHN.

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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-ABSORBK830652ANTI N DNA-HCPK821576ANTINUCLEAR ANTIBODY SCREEN FLOURESC

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Related Devices (Code: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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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