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 Plasma, Coagulation Control
510(k) Number K042209
Device Name CONTROL PLASMA N AND CONTROL PLASMA P
Applicant
Dade Behring, Inc.
514 Gbc Dr.
Newark,  DE  19702
Applicant Contact DONNA A WOLF
Correspondent
Dade Behring, Inc.
514 Gbc Dr.
Newark,  DE  19702
Correspondent Contact DONNA A WOLF
Regulation Number864.5425
Classification Product Code
GGN  
Subsequent Product Codes
GGC   GIZ  
Date Received08/16/2004
Decision Date 10/21/2004
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
-
-