AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM— 510(k) K851361

Name: FDA 510(k) clearance K851361
Creator: U.S. Food and Drug Administration
Published: 1985-05-07

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K851361 for AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM, Substantially Equivalent on 1985-05-07. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1985-04-04
Decision date: 1985-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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