PEAK OVULATION PREDICTOR
FDA 510(k) clearance K863121 · decided 1986-10-14
Clearance details
- K-number
- K863121
- Device name
- PEAK OVULATION PREDICTOR
- Applicant
- Micron Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-14
- Decision date
- 1986-10-14
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- NGE
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boise, ID, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Micron Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FERTILITE OV (K020808) | Pheromone Sciences Corp. | 2002-09-23 |
| MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223) | Unipath , Ltd. | 1999-02-24 |
| CLEARPLAN EASY FERTILITY MONITOR (K981207) | Unipath , Ltd. | 1998-10-28 |
| OVULON MONITOR (K973860) | Conception Technology, Inc. | 1998-01-07 |
| CUE FERTILITY MONITOR (K850579) | Zetek, Inc. | 1985-03-22 |
Recalls involving this device
No recalls on record reference this clearance.