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 Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K030555
Device Name GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact LONNIE WITHAM
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact LONNIE WITHAM
Regulation Number862.2050
Classification Product Code
JQC  
Date Received02/21/2003
Decision Date 04/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-