VIDAS D-DIMER EXCLUSION II (DEX2)— 510(k) K112818

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K112818 for VIDAS D-DIMER EXCLUSION II (DEX2), Substantially Equivalent on 2012-07-31. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2011-09-28
Decision date: 2012-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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