VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442


Device Classification Name

fibrinogen and fibrin split products, antigen, antiserum, control

510(k) Number K030328
Device Name VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Original Contact sandra perreand
Regulation Number 864.7320
Classification Product Code
DAP  
Date Received 01/31/2003
Decision Date 09/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No