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 K032611
Device Name LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618
Applicant Contact MARIA ZEBALLOS
Correspondent
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618
Correspondent Contact MARIA ZEBALLOS
Regulation Number864.5425
Classification Product Code
GGN  
Date Received08/25/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-