The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Sickle Cell Test.
| Device ID | K960947 |
| 510k Number | K960947 |
| Device Name: | SAS SICKLE CELL TEST |
| Classification | Test, Sickle Cell |
| 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 | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-08 |
| Decision Date | 1996-07-01 |