MODIFICATION TO STANDARD HUMAN PLASMA


Device Classification Name

system, multipurpose for in vitro coagulation studies

510(k) Number K023141
Device Name MODIFICATION TO STANDARD HUMAN PLASMA
Original Applicant
DADE BEHRING, INC.
514 gbc dr.
newark, 
DE 
19702

Original Contact donna a wolf
Regulation Number 864.5425
Classification Product Code
JPA  
Date Received 09/20/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No