VIDAS D-DIMER (DD) ASSAY— 510(k) K973819

Name: FDA 510(k) clearance K973819
Creator: U.S. Food and Drug Administration
Published: 1998-03-10

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K973819 for VIDAS D-DIMER (DD) ASSAY, Substantially Equivalent on 1998-03-10. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1997-10-07
Decision date: 1998-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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