Panels › Clinical Chemistry › Product code NGE · Class 1
Test, Luteinizing Hormone (Lh), Over The Counter
Regulation 862.1485
0510(k)s in 12 months (6 all time)
2recalls in 12 months (10 all time)
1recalls that name a 510(k)
Top companies in NGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Universal Meditech Inc. | 0 | 7 |
| Unipath , Ltd. | 2 | 0 |
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| Conception Technology, Inc. | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Micron Technology, Inc. | 1 | 0 |
| Pheromone Sciences Corp. | 1 | 0 |
| Quest Products Inc. | 0 | 1 |
| Zetek, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2002 | K020808 | FERTILITE OV Pheromone Sciences Corp., CA | NGE |
| Feb 24, 1999 | K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR Unipath , Ltd., GB | NGE |
| Oct 28, 1998 | K981207 | CLEARPLAN EASY FERTILITY MONITOR Unipath , Ltd., GB | NGE |
| Jan 7, 1998 | K973860 | OVULON MONITOR Conception Technology, Inc. | NGE |
| Oct 14, 1986 | K863121 | PEAK OVULATION PREDICTOR Micron Technology, Inc. | NGE |
| Mar 22, 1985 | K850579 | CUE FERTILITY MONITOR Zetek, Inc. | NGE |
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