Elecsys sFlt-1 and Elecsys PlGF— 510(k) K241453
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K241453 for Elecsys sFlt-1 and Elecsys PlGF, Substantially Equivalent on 2025-02-07. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code QWH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1602
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code QWH
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