Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name fibrinogen and fibrin split products, antigen, antiserum, control
510(K) Number K040882
Device Name VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood,  MO  63042
Contact sandra perreand
Regulation Number864.7320
Classification Product Code
DAP  
Date Received04/05/2004
Decision Date 06/10/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-