The following data is part of a premarket notification filed by Pheromone Sciences Corp. with the FDA for Fertilite Ov.
| Device ID | K020808 |
| 510k Number | K020808 |
| Device Name: | FERTILITE OV |
| Classification | Test, Luteinizing Hormone (lh), Over The Counter |
| Applicant | PHEROMONE SCIENCES CORP. 443 KING ST. EAST 2ND FL Toronto, CA M5a 1l5 |
| Contact | Jeffrey T Solate |
| Correspondent | Jeffrey T Solate PHEROMONE SCIENCES CORP. 443 KING ST. EAST 2ND FL Toronto, CA M5a 1l5 |
| Product Code | NGE |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-12 |
| Decision Date | 2002-09-23 |
| Summary: | summary |