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FDA 510(k)

FIAX TEST FOR ANTI-RUBELLA ANTIBODY

K-Number: K772219 · 1978-01-20

ApplicantIdt, A Division of Whittaker M.A. Bioproducts
Decision Date1978-01-20
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX TEST FOR ANTI-RUBELLA ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K772219. 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 FIAX TEST FOR ANTI-RUBELLA ANTIBODY?

FIAX TEST FOR ANTI-RUBELLA ANTIBODY is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. The 510(k) number is K772219.

When did FIAX TEST FOR ANTI-RUBELLA ANTIBODY receive FDA 510(k) clearance?

FIAX TEST FOR ANTI-RUBELLA ANTIBODY received FDA 510(k) clearance on 1978-01-20, under 510(k) number K772219.

Who is the listed applicant for FIAX TEST FOR ANTI-RUBELLA ANTIBODY?

The FDA 510(k) record lists Idt, A Division of Whittaker M.A. Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIAX TEST FOR ANTI-RUBELLA ANTIBODY?

The FDA product code for FIAX TEST FOR ANTI-RUBELLA ANTIBODY is DHN.

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Other records listing Idt, A Division of Whittaker M.A. Bioproducts 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.

K853540FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGYK853067FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENTK782041FIAX TEST KITK772114FIAX C4 ASSAY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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