SAS INFLUENZA A & B TEST


Device Classification Name

antigens, cf (including cf control), influenza virus a, b, c

510(k) Number K080380
Device Name SAS INFLUENZA A & B TEST
Applicant
SA SCIENTIFIC, INC.
4919 golden quail
san antonio, 
TX 
78240

Applicant Contact robbi perry
Correspondent
SA SCIENTIFIC, INC.
4919 golden quail
san antonio, 
TX 
78240

Correspodent Contact robbi perry
Regulation Number 866.3330
Classification Product Code
GNX  
Date Received 02/13/2008
Decision Date 07/23/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No