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FDA 510(k)

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT

K-Number: K853067 · 1985-10-22

ApplicantIdt, A Division of Whittaker M.A. Bioproducts
Decision Date1985-10-22
Product CodeGRE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT 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 1985-10-22 under 510(k) number K853067. The device is classified under product code GRE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT?

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT is a medical device that received FDA 510(k) clearance on 1985-10-22. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. The 510(k) number is K853067.

When did FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT receive FDA 510(k) clearance?

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT received FDA 510(k) clearance on 1985-10-22, under 510(k) number K853067.

Who is the listed applicant for FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT?

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 FOR MEASLES-G ANTIBODIES FLYORESCENT?

The FDA product code for FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT is GRE.

Related Clinical Trials

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.

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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 SEROLOGYK782041FIAX TEST KITK772219FIAX TEST FOR ANTI-RUBELLA ANTIBODYK772114FIAX C4 ASSAY

Related Devices (Code: GRE)

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.

K884004RUBEOLA TESTGull Laboratories, Inc.K821249ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUSElectro-Nucleonics Laboratories, Inc.K770687MEASLESVIRUS FLOURE. CONJUGATED ANTISERUMicrobiological Assoc.

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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