AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086— 510(k) K914135

Name: FDA 510(k) clearance K914135
Creator: U.S. Food and Drug Administration
Published: 1992-02-18

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K914135 for AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086, Substantially Equivalent on 1992-02-18. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1991-09-16
Decision date: 1992-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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