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 System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K984501
Device Name DADE BEHRING BFTII
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Applicant Contact CAROLYN K GEORGE
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Correspondent Contact CAROLYN K GEORGE
Regulation Number864.5425
Classification Product Code
JPA  
Date Received12/18/1998
Decision Date 07/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-