The following data is part of a premarket notification filed by Micron Technology, Inc. with the FDA for Peak Ovulation Predictor.
| Device ID | K863121 |
| 510k Number | K863121 |
| Device Name: | PEAK OVULATION PREDICTOR |
| Classification | Test, Luteinizing Hormone (lh), Over The Counter |
| Applicant | MICRON TECHNOLOGY, INC. 2805 E. COLUMBIA RD. Boise, ID 83706 |
| Contact | Kipp Bedard |
| Correspondent | Kipp Bedard MICRON TECHNOLOGY, INC. 2805 E. COLUMBIA RD. Boise, ID 83706 |
| Product Code | NGE |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-14 |
| Decision Date | 1986-10-14 |