510(k) K030555

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A by Biomet, Inc. — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2003
Date Received
February 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type