AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT— 510(k) K851104

Name: FDA 510(k) clearance K851104
Creator: U.S. Food and Drug Administration
Published: 1985-04-10

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K851104 for AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT, Substantially Equivalent on 1985-04-10. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1985-03-19
Decision date: 1985-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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