The following data is part of a premarket notification filed by Biogenex Laboratories with the FDA for Modified Ovugen.
| Device ID | K902208 |
| 510k Number | K902208 |
| Device Name: | MODIFIED OVUGEN |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | BIOGENEX LABORATORIES 4600 NORRIS CANYON RD. San Ramon, CA 94583 |
| Contact | Krishan L Kalra,phd |
| Correspondent | Krishan L Kalra,phd BIOGENEX LABORATORIES 4600 NORRIS CANYON RD. San Ramon, CA 94583 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-07-17 |