AMERLITE PROLACTIN-30 ASSAY— 510(k) K922170

Name: FDA 510(k) clearance K922170
Creator: U.S. Food and Drug Administration
Published: 1992-09-02

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K922170 for AMERLITE PROLACTIN-30 ASSAY, Substantially Equivalent on 1992-09-02. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1992-05-08
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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