Panels › Clinical Chemistry › Product code QWH · Class 2
Prognostic Test For Development Or Progression Of Preeclampsia
Regulation 862.1602
0510(k)s in 12 months (2 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Brahms GmbH | 0 | 1 |
| Brahms GmbH, Part of Thermo Fisher Scientific | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2025 | K241453 | Elecsys sFlt-1 and Elecsys PlGF Roche Diagnostics | QWH |
| May 18, 2023 | DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System Brahms GmbH, Part of Thermo Fisher Scientific, DE | QWH |
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