The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Signal Pregnancy Test Kit.
| Device ID | K974021 |
| 510k Number | K974021 |
| Device Name: | SIGNAL PREGNANCY TEST KIT |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-22 |
| Decision Date | 1997-12-19 |
| Summary: | summary |