FDA Product Code
FDA Product Code NGE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1485
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020808 | FERTILITE OV | Pheromone Sciences Corp. | 2002-09-23 | Traditional | PDF ↗ |
| K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | 1999-02-24 | Special | PDF ↗ |
| K981207 | CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | 1998-10-28 | Traditional | PDF ↗ |
| K973860 | OVULON MONITOR | Conception Technology, Inc. | 1998-01-07 | Traditional | PDF ↗ |
| K863121 | PEAK OVULATION PREDICTOR | Micron Technology, Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K850579 | CUE FERTILITY MONITOR | Zetek, Inc. | 1985-03-22 | Traditional | PDF ↗ |
Product code NGE · Class I · Clinical Chemistry. Data: openFDA.