The following data is part of a premarket notification filed by Biogenex Laboratories with the FDA for Pregnagen 1-step Pregnancy Test.
| Device ID | K925189 |
| 510k Number | K925189 |
| Device Name: | PREGNAGEN 1-STEP PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIOGENEX LABORATORIES 10366 B ROSELLE ST. San Diego, CA 92121 |
| Contact | Shung-ho Chang |
| Correspondent | Shung-ho Chang BIOGENEX LABORATORIES 10366 B ROSELLE ST. San Diego, CA 92121 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-01-06 |