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FDA 510(k)

AMERLITE MAB FT4 ASSAY

K-Number: K955097 · 1995-12-20

ApplicantKodak Clinical Diagnostics, Ltd.
Decision Date1995-12-20
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE MAB FT4 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Kodak Clinical Diagnostics, Ltd.. It received FDA 510(k) clearance on 1995-12-20 under 510(k) number K955097. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE MAB FT4 ASSAY?

AMERLITE MAB FT4 ASSAY is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Kodak Clinical Diagnostics, Ltd.. The 510(k) number is K955097.

When did AMERLITE MAB FT4 ASSAY receive FDA 510(k) clearance?

AMERLITE MAB FT4 ASSAY received FDA 510(k) clearance on 1995-12-20, under 510(k) number K955097.

Who is the listed applicant for AMERLITE MAB FT4 ASSAY?

The FDA 510(k) record lists Kodak Clinical Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERLITE MAB FT4 ASSAY?

The FDA product code for AMERLITE MAB FT4 ASSAY is CEC.

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Related Devices (Code: CEC)

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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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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