The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Strepalert.
| Device ID | K023270 |
| 510k Number | K023270 |
| Device Name: | SAS STREPALERT |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Ricardo R Martinez |
| Correspondent | Ricardo R Martinez 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 | 2002-10-01 |
| Decision Date | 2002-10-17 |