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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. LH One Step Ovulation Test Device (Urine) Open, Classified |
NGE | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Ovulation Test (5 tests) Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. OMTMO One Step Ovulation (LH) Test Strips REF 200-07 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS Ovulation Predictor Midstream REF 200-17 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. Lem Fertility LH Ovulation Test (Strip) REF 200-07 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS One Step LH Ovulation Test Strip REF 200-07 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips Open, Classified |
NGE | K110889 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. One Step Ovulation Test REF 200-01 Open, Classified |
NGE | None listed |
| Mar 3, 2010 | Quest Products Inc. OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator f Terminated |
NGE | None listed |
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