The following data is part of a premarket notification filed by Biogenex Laboratories with the FDA for Ovugen Suretest.
| Device ID | K873534 |
| 510k Number | K873534 |
| Device Name: | OVUGEN SURETEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | BIOGENEX LABORATORIES 6549 SIERRA LN. Dublin, CA 94568 |
| Contact | Kalra, Phd |
| Correspondent | Kalra, Phd BIOGENEX LABORATORIES 6549 SIERRA LN. Dublin, CA 94568 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-01 |
| Decision Date | 1987-11-23 |