The following data is part of a premarket notification filed by Conception Technology, Inc. with the FDA for Ovulon Monitor.
| Device ID | K973860 |
| 510k Number | K973860 |
| Device Name: | OVULON MONITOR |
| Classification | Test, Luteinizing Hormone (lh), Over The Counter |
| Applicant | CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. Ft. Collins, CO 80524 |
| Contact | Terry R Knapp, Md |
| Correspondent | Terry R Knapp, Md CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. Ft. Collins, CO 80524 |
| Product Code | NGE |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-09 |
| Decision Date | 1998-01-07 |