VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442— 510(k) K040882

Name: FDA 510(k) clearance K040882
Creator: U.S. Food and Drug Administration
Published: 2004-06-10

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K040882 for VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442, Substantially Equivalent on 2004-06-10. Applicant: bioMerieux, Inc.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2004-04-05
Decision date: 2004-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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