25-Oh-Vitamin D Mass Spectrometry Test System

PSL · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1840

Classification

FDA Product Code: PSL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1840
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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