COLOR-MONOGEN— 510(k) K012901

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K012901 for COLOR-MONOGEN, Substantially Equivalent on 2001-09-27. Applicant: Instrumentation Laboratory CO.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code KTN
Advisory panel: Immunology
Date received: 2001-08-29
Decision date: 2001-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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