AMERLITE TT4 ASSAY (240/480/144 TEST KITS)— 510(k) K873976

Name: FDA 510(k) clearance K873976
Creator: U.S. Food and Drug Administration
Published: 1987-11-05

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K873976 for AMERLITE TT4 ASSAY (240/480/144 TEST KITS), Substantially Equivalent on 1987-11-05. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-09-29
Decision date: 1987-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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