The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Quant Hcg Serum.
| Device ID | K944785 |
| 510k Number | K944785 |
| Device Name: | SAS QUANT HCG SERUM |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-28 |
| Decision Date | 1995-01-17 |