The following data is part of a premarket notification filed by San Diego Biotech with the FDA for San Diego Biotech Hcg Pregnancy Urine Test.
| Device ID | K974851 |
| 510k Number | K974851 |
| Device Name: | SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SAN DIEGO BIOTECH 7919 SILVERTON AVE., #409/410 San Diego, CA 92126 |
| Contact | Chai Bunjagidj |
| Correspondent | Chai Bunjagidj SAN DIEGO BIOTECH 7919 SILVERTON AVE., #409/410 San Diego, CA 92126 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-01-22 |