QUANTEX D-DIMER— 510(k) K032419

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K032419 for QUANTEX D-DIMER, Substantially Equivalent on 2003-10-24. Applicant: Instrumentation Laboratory CO.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DAP
Advisory panel: Hematology
Date received: 2003-08-05
Decision date: 2003-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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