The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas One-step Pregnancy.
| Device ID | K964995 |
| 510k Number | K964995 |
| Device Name: | SAS ONE-STEP PREGNANCY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Kathryn Kelley |
| Correspondent | Kathryn Kelley SA SCIENTIFIC, INC. 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 | 1997-01-21 |