510(k) K241453
- Device
- Elecsys sFlt-1 and Elecsys PlGF
- Applicant
- Roche Diagnostics
- 510(k) number
- K241453
- Product code
- QWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-07
- Date received
- 2024-05-22
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jane Phillips
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3005847079
- 3003561301
- 9610126
Source Documents#
Other 510(k) Records For Product Code QWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | 2023-05-18 |