The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Febrile Antigen Set.
| Device ID | K952131 |
| 510k Number | K952131 |
| Device Name: | SAS FEBRILE ANTIGEN SET |
| Classification | Antigens (febrile), Agglutination, Brucella 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 | GSO |
| CFR Regulation Number | 866.3085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-07-17 |