Panels › Clinical Chemistry › Product code NGA · Class 1
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Regulation 862.1300
0510(k)s in 12 months (2 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in NGA
| Company | 510(k)s | Recalls |
|---|---|---|
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| Genosis, Inc. | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Quantrx Biomedical Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2007 | K070484 | QUANTRX FEMALE FERTILITY TEST Quantrx Biomedical Corporation | NGA |
| Oct 30, 2003 | K032002 | FERTELL FEMALE FERTILITY TEST Genosis, Inc. | NGA |
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