SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM


Device Classification Name

antisera, all groups, salmonella spp.

510(k) Number K960123
Device Name SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM
Applicant
SA SCIENTIFIC, INC.
4919 golden quail
san antonio, 
TX 
78240

Applicant Contact harbi shadfan
Correspondent
SA SCIENTIFIC, INC.
4919 golden quail
san antonio, 
TX 
78240

Correspodent Contact harbi shadfan
Regulation Number 866.3550
Classification Product Code
GRM  
Date Received 01/11/1996
Decision Date 03/06/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No