The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Hcg-check.
| Device ID | K991193 |
| 510k Number | K991193 |
| Device Name: | SAS HCG-CHECK |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | J. Wessling |
| Correspondent | J. Wessling SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-08 |
| Decision Date | 1999-05-04 |