ASSERACHROM PROTEIN C KIT— 510(k) K854016

Name: FDA 510(k) clearance K854016
Creator: U.S. Food and Drug Administration
Published: 1986-01-03

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K854016 for ASSERACHROM PROTEIN C KIT, Substantially Equivalent on 1986-01-03. Applicant: American Bioproducts Co.. Device class: 1.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code JLA
Device class: Class 1
Regulation: 21 CFR 862.1210
Advisory panel: Clinical Chemistry
Date received: 1985-09-27
Decision date: 1986-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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