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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2004 | K042750 | QC-BEADS Bioscreen, Inc. | NRF |
| Jul 27, 2004 | K041600 | QWIKCHECK-BEADS Medical Electronics Systems , Ltd. | NRF |
| Jun 2, 2004 | K041240 | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED Fertility Solutions, Inc. | NRF |
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