COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS— 510(k) K022550

Name: FDA 510(k) clearance K022550
Creator: U.S. Food and Drug Administration
Published: 2002-08-27

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K022550 for COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS, Substantially Equivalent on 2002-08-27. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 2002-08-02
Decision date: 2002-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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