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FDA 510(k)

FIAX C4 ASSAY

K-Number: K772114 · 1977-11-30

ApplicantIdt, A Division of Whittaker M.A. Bioproducts
Decision Date1977-11-30
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX C4 ASSAY 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 1977-11-30 under 510(k) number K772114. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX C4 ASSAY?

FIAX C4 ASSAY is a medical device that received FDA 510(k) clearance on 1977-11-30. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. The 510(k) number is K772114.

When did FIAX C4 ASSAY receive FDA 510(k) clearance?

FIAX C4 ASSAY received FDA 510(k) clearance on 1977-11-30, under 510(k) number K772114.

Who is the listed applicant for FIAX C4 ASSAY?

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 C4 ASSAY?

The FDA product code for FIAX C4 ASSAY is DAK.

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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 KITK772219FIAX TEST FOR ANTI-RUBELLA ANTIBODY

Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.

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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