AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)— 510(k) K860253

Name: FDA 510(k) clearance K860253
Creator: U.S. Food and Drug Administration
Published: 1986-03-14

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K860253 for AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT), Substantially Equivalent on 1986-03-14. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code CHO
Device class: Class 2
Regulation: 21 CFR 862.1230
Advisory panel: Clinical Chemistry
Date received: 1986-01-24
Decision date: 1986-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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