FDA Product Code
FDA Product Code QWH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1602
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | 2025-02-07 | Traditional | PDF ↗ |
| DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | 2023-05-18 | Direct | — |
Product code QWH · Class II · Clinical Chemistry. Data: openFDA.