JQT

18 FDA 510(k) clearances · Product code

FDA profile

Official device name

Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Device class

Class I (low risk)

Regulation

21 CFR 862.2400

Medical specialty

Clinical Chemistry

Adverse events (MAUDE)

2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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