The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Blood/serum/urine/urine Hcg.
| Device ID | K022683 |
| 510k Number | K022683 |
| Device Name: | SAS BLOOD/SERUM/URINE/URINE HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Ricardo R Martinez |
| Correspondent | Ricardo R Martinez 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 | 2002-08-12 |
| Decision Date | 2002-12-16 |
| Summary: | summary |