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FDA 510(k)

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

K-Number: K871801 · 1987-06-09

ApplicantCytotech, Inc.
Decision Date1987-06-09
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cytotech, Inc.. It received FDA 510(k) clearance on 1987-06-09 under 510(k) number K871801. 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 CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT?

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT is a medical device that received FDA 510(k) clearance on 1987-06-09. The listed applicant is Cytotech, Inc.. The 510(k) number is K871801.

When did CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT receive FDA 510(k) clearance?

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT received FDA 510(k) clearance on 1987-06-09, under 510(k) number K871801.

Who is the listed applicant for CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT?

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

What is the FDA product code for CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT?

The FDA product code for CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT is DHN.

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Other records listing Cytotech, 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.

K882829CIRCULATING IMMUNE COMPLEXES CONTROLSK874379CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAYK873249ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLSK872426CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYK864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAYK862838CYTOTECH HSV IGG ENZYME IMMUNOASSAY

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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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