FDA 510(k) K973860, OVULON MONITOR, by Conception Technology, Inc.
FDA 510(k) K973860, OVULON MONITOR, by Conception Technology, Inc.
| 510(k) Number | K973860 |
| Device Classification Name | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device Name | OVULON MONITOR |
| Applicant | Conception Technology, Inc. 214 S. College Ave. Ft. Collins, CO 80524 |
| Regulation Number | 862.1485 |
| Classification Product Code | NGE |
| Date Received | 10/09/1997 |
| Decision Date | 01/07/1998 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Clinical Chemistry |
| 510k Review Panel | Toxicology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 241 |
| Redacted Pages | 137 |
| Unredacted Pages | 104 |
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