Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FIAX TEST KIT

K-Number: K782041 · 1979-01-03

ApplicantIdt, A Division of Whittaker M.A. Bioproducts
Decision Date1979-01-03
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT 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 1979-01-03 under 510(k) number K782041. 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 KIT?

FIAX TEST KIT is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. The 510(k) number is K782041.

When did FIAX TEST KIT receive FDA 510(k) clearance?

FIAX TEST KIT received FDA 510(k) clearance on 1979-01-03, under 510(k) number K782041.

Who is the listed applicant for FIAX TEST KIT?

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 KIT?

The FDA product code for FIAX TEST KIT is DHN.

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 FLYORESCENTK772219FIAX TEST FOR ANTI-RUBELLA ANTIBODYK772114FIAX 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

View on FDA Database →

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

↑