AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)— 510(k) K883878

Name: FDA 510(k) clearance K883878
Creator: U.S. Food and Drug Administration
Published: 1988-11-01

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K883878 for AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144), Substantially Equivalent on 1988-11-01. 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: 1988-09-13
Decision date: 1988-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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