Menopause Test System

QDH · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1093

Classification

FDA Product Code: QDH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1093
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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