COAMATIC AT-400— 510(k) K022195

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K022195 for COAMATIC AT-400, Substantially Equivalent on 2002-08-07. 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: 2002-07-05
Decision date: 2002-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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