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FDA 510(k)

KODAK AMERLEX MAB FT3 ASSAY

K-Number: K922771 · 1992-10-14

ApplicantEastman Kodak Company
Decision Date1992-10-14
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK AMERLEX MAB FT3 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1992-10-14 under 510(k) number K922771. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK AMERLEX MAB FT3 ASSAY?

KODAK AMERLEX MAB FT3 ASSAY is a medical device that received FDA 510(k) clearance on 1992-10-14. The listed applicant is Eastman Kodak Company. The 510(k) number is K922771.

When did KODAK AMERLEX MAB FT3 ASSAY receive FDA 510(k) clearance?

KODAK AMERLEX MAB FT3 ASSAY received FDA 510(k) clearance on 1992-10-14, under 510(k) number K922771.

Who is the listed applicant for KODAK AMERLEX MAB FT3 ASSAY?

The FDA 510(k) record lists Eastman Kodak Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODAK AMERLEX MAB FT3 ASSAY?

The FDA product code for KODAK AMERLEX MAB FT3 ASSAY is CDP.

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Other records listing Eastman Kodak Company as applicant

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K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983434ABBOTT ARCHITECT TOTAL T3Abbott Laboratories

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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