PROTEIN S AC


Device Classification Name

test, qualitative and quantitative factor deficiency

510(k) Number K022290
Device Name PROTEIN S AC
Original Applicant
DADE BEHRING, INC.
514 gbc dr.
newark, 
DE 
19702

Original Contact donna a wolf
Regulation Number 864.7290
Classification Product Code
GGP  
Date Received 07/15/2002
Decision Date 08/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No