AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST— 510(k) K881142

Name: FDA 510(k) clearance K881142
Creator: U.S. Food and Drug Administration
Published: 1988-07-21

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K881142 for AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST, Substantially Equivalent on 1988-07-21. 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: 1988-03-17
Decision date: 1988-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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