The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Brucella Ams Antiserum.
| Device ID | K952132 |
| 510k Number | K952132 |
| Device Name: | SAS BRUCELLA AMS ANTISERUM |
| Classification | Antisera, Fluorescent, Brucella Spp. |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Shadfan |
| Correspondent | Shadfan SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | GSM |
| 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 | 1995-07-21 |