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510(k) DEN220027

B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System by Brahms GmbH, Part of Thermo Fisher Scientific — Product Code QWH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 18, 2023
Date Received
May 2, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prognostic Test For Development Or Progression Of Preeclampsia
Device Class
Class II
Regulation Number
862.1602
Review Panel
TX
Submission Type

A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.

Other clearances for product code QWH

  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)