QWH — Prognostic Test For Development Or Progression Of Preeclampsia Class II
FDA product code QWH covers "Prognostic Test For Development Or Progression Of Preeclampsia", a Class II medical device regulated under 21 CFR 862.1602. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QWH
- Device Class
- Class II
- Regulation Number
- 862.1602
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
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.