COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY— 510(k) K915083

Name: FDA 510(k) clearance K915083
Creator: U.S. Food and Drug Administration
Published: 1992-01-03

Substantially Equivalent

Kabi Pharmacia, Inc.

FDA 510(k) clearance K915083 for COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY, Substantially Equivalent on 1992-01-03. Applicant: Kabi Pharmacia, Inc.. Device class: 2.

Clearance details

Applicant: Kabi Pharmacia, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1991-11-12
Decision date: 1992-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, OH, US

Download summary PDF View on FDA.gov ↗

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