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FDA 510(k)

AMERLITE PROLACTIN-30 ASSAY

K-Number: K922170 · 1992-09-02

ApplicantEastman Kodak Company
Decision Date1992-09-02
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE PROLACTIN-30 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 1992-09-02 under 510(k) number K922170. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE PROLACTIN-30 ASSAY?

AMERLITE PROLACTIN-30 ASSAY is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Eastman Kodak Company. The 510(k) number is K922170.

When did AMERLITE PROLACTIN-30 ASSAY receive FDA 510(k) clearance?

AMERLITE PROLACTIN-30 ASSAY received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922170.

Who is the listed applicant for AMERLITE PROLACTIN-30 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 AMERLITE PROLACTIN-30 ASSAY?

The FDA product code for AMERLITE PROLACTIN-30 ASSAY is CFT.

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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: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems 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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