Panels › Hematology › Product code NRF · Class 2
Material, Quality Control, Semen Analysis
Regulation 864.8625
0510(k)s in 12 months (3 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in NRF
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioscreen, Inc. | 1 | 0 |
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| Fertility Solutions, Inc. | 1 | 0 |
| Medical Electronics Systems , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Male Fertility Sperm Test for Home Use (Cassette) Open, Classified |
NRF | None listed |
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