AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT— 510(k) K912733

Name: FDA 510(k) clearance K912733
Creator: U.S. Food and Drug Administration
Published: 1991-07-22

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K912733 for AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT, Substantially Equivalent on 1991-07-22. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1991-06-20
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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