QWH

Prognostic Test For Development Or Progression Of Preeclampsia

Product code

QWH

Device name

Prognostic Test For Development Or Progression Of Preeclampsia

Device class

Class 2

21 CFR

21 CFR 862.1602

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-02-07.

1 summaries are archived here for direct download.