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FDA 510(k)

HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM

K-Number: K926114 · 1993-05-20

ApplicantTissue Culture Biotec, Inc.
Decision Date1993-05-20
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Culture Biotec, Inc.. It received FDA 510(k) clearance on 1993-05-20 under 510(k) number K926114. 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 HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM?

HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Tissue Culture Biotec, Inc.. The 510(k) number is K926114.

When did HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1993-05-20, under 510(k) number K926114.

Who is the listed applicant for HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM?

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

What is the FDA product code for HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM?

The FDA product code for HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM is DHN.

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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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