The following data is part of a premarket notification filed by Ob/gyn Concepts, Ltd. with the FDA for Ovu-trac Ovulation Timing Kit.
| Device ID | K870528 |
| 510k Number | K870528 |
| Device Name: | OVU-TRAC OVULATION TIMING KIT |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | OB/GYN CONCEPTS, LTD. 613 DOCK DR. Barrington, IL 60010 |
| Contact | Charles B Root |
| Correspondent | Charles B Root OB/GYN CONCEPTS, LTD. 613 DOCK DR. Barrington, IL 60010 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-05 |
| Decision Date | 1987-05-06 |