AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED— 510(k) K844408

Name: FDA 510(k) clearance K844408
Creator: U.S. Food and Drug Administration
Published: 1984-12-11

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K844408 for AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED, Substantially Equivalent on 1984-12-11. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1984-11-14
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.