The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Strep A Test.
| Device ID | K993456 |
| 510k Number | K993456 |
| Device Name: | SAS STREP A TEST |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Harbi A Shadfan |
| Correspondent | Harbi A Shadfan SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 2000-03-07 |