The following data is part of a premarket notification filed by Sascie with the FDA for Sas Pregnancy Strip.
| Device ID | K965253 |
| 510k Number | K965253 |
| Device Name: | SAS PREGNANCY STRIP |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SASCIE 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Harbi Shadfan |
| Correspondent | Harbi Shadfan SASCIE 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-16 |
| Decision Date | 1997-02-18 |