510(k) DEN220027
- Device
- B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- Applicant
- Brahms GmbH, Part of Thermo Fisher Scientific
- 510(k) number
- DEN220027
- Product code
- QWH
- Decision
- Unknown (DENG)
- Decision date
- 2023-05-18
- Date received
- 2022-05-02
- Regulation
- 862.1602
- Classification name
- Prognostic Test For Development Or Progression Of Preeclampsia
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Anja Jagalla
- Address
- Neuensdorfstrasse 25 Hennigsdorf DE 16761 16761
FDA Registration Numbers#
- 3005847079
- 3003561301
- 9610126
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | 2025-02-07 |