Prognostic Test For Development Or Progression Of Preeclampsia

QWH · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1602

Classification

FDA Product Code: QWH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1602
Review panel: TX
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown