AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL— 510(k) K920576

Name: FDA 510(k) clearance K920576
Creator: U.S. Food and Drug Administration
Published: 1992-03-23

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K920576 for AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL, Substantially Equivalent on 1992-03-23. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1992-02-10
Decision date: 1992-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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