UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K974721

Name: FDA 510(k) clearance K974721
Creator: U.S. Food and Drug Administration
Published: 1998-03-03

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K974721 for UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1998-03-03. Applicant: Bayer Corp.. Device class: 1.

Clearance details

Applicant: Bayer Corp.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1997-12-18
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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