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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 K020810
Device Name VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact SANDRA PERREAND
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact SANDRA PERREAND
Regulation Number864.7320
Classification Product Code
DAP  
Date Received03/13/2002
Decision Date 10/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-