VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442— 510(k) K030328

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K030328 for VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442, Substantially Equivalent on 2003-09-02. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2003-01-31
Decision date: 2003-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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