The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Surevue Serum/urine Hcg, Model 1,30,50,100 Test Kit.
| Device ID | K010593 |
| 510k Number | K010593 |
| Device Name: | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Arbi A Shadfan |
| Correspondent | Arbi A Shadfan 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 | 2001-02-28 |
| Decision Date | 2001-04-05 |