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FDA 510(k)

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES

K-Number: K970198 · 1997-02-20

ApplicantScimedx Corp.
Decision Date1997-02-20
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Corp.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K970198. 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 IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES?

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Scimedx Corp.. The 510(k) number is K970198.

When did IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES receive FDA 510(k) clearance?

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES received FDA 510(k) clearance on 1997-02-20, under 510(k) number K970198.

Who is the listed applicant for IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES?

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

What is the FDA product code for IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES?

The FDA product code for IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES is DHN.

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Other records listing Scimedx Corp. 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.

K011348PHASE II GBM IGG ANTIBODY EIA TESTK011082TPO IGG ANTIBODY EIA TESTK010625EUROSPITAL EU-TTG IGA UMANAK010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAK010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAK002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

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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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