510(k) DEN220027
DEN220027 is an FDA 510(k) premarket notification submitted by Brahms GmbH, Part of Thermo Fisher Scientific for the device "B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System". The FDA issued a decision of De Novo Granted on May 18, 2023. The device falls under product code QWH (Prognostic Test For Development Or Progression Of Preeclampsia), a Class II device regulated under 21 CFR 862.1602.
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.