NGE
6 FDA 510(k) clearances · Product code
90 daysmedian time to decision
209 days90th percentile
6clearances measured
FDA profile
- Official device name
- Test, Luteinizing Hormone (Lh), Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| PEAK OVULATION PREDICTOR (K863121) | Micron Technology, Inc. | 1986-10-14 |
| CUE FERTILITY MONITOR (K850579) | Zetek, Inc. | 1985-03-22 |
Track NGE automatically
Every clearance here is in the API, with alerts when new ones post.