BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010


Device Classification Name

counter, differential cell

510(k) Number K081213
Device Name BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
Applicant
BD Biosciences
2350 qume dr.
san jose, 
CA 
95131 -1807

Applicant Contact nobuko nakajima
Correspondent
BD Biosciences
2350 qume dr.
san jose, 
CA 
95131 -1807

Correspodent Contact nobuko nakajima
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 04/30/2008
Decision Date 08/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls