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 Prothrombin Fragment 1.2
510(k) Number K042687
Device Name ENZYGNOST F+2 (MONOCLONAL) TEST KIT
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact DONNA WOLF
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact DONNA WOLF
Regulation Number864.7320
Classification Product Code
MIF  
Date Received09/29/2004
Decision Date 12/10/2004
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
Predetermined Change
Control Plan Authorized		 No
-
-