GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A


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 -0587

Applicant Contact lonnie witham
Correspondent
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact lonnie witham
Regulation Number 862.2050
Classification Product Code
JQC  
Date Received 02/21/2003
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