The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Salmonella E,n,x Antiserum.
| Device ID | K955214 |
| 510k Number | K955214 |
| Device Name: | SAS SALMONELLA E,N,X ANTISERUM |
| Classification | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Harbi Shadfan |
| Correspondent | Harbi Shadfan SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | GNC |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-14 |
| Decision Date | 1996-02-07 |