VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN


Device Classification Name

plasma, coagulation control

510(k) Number K110432
Device Name VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
Applicant
AFFINITY BIOLOGICALS INC.
1395 sandhill drive
ancaster, ontario, 

CA

l9g 4v5

Applicant Contact denise foulon
Correspondent
AFFINITY BIOLOGICALS INC.
1395 sandhill drive
ancaster, ontario, 

CA

l9g 4v5

Correspodent Contact denise foulon
Regulation Number 864.5425
Classification Product Code
GGN  
Date Received 02/15/2011
Decision Date 10/20/2011
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