CONTROL PLASMA P


Device Classification Name

control, plasma, abnormal

510(k) Number K023312
Device Name CONTROL PLASMA P
Original Applicant
DADE BEHRING, INC.
514 gbc dr.
newark, 
DE 
19702

Original Contact donna a wolf
Regulation Number 864.5425
Classification Product Code
GGC  
Date Received 10/03/2002
Decision Date 11/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No