JIQ

13 FDA 510(k) clearances · Product code

FDA profile

Official device name

Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Device class

Class I (low risk)

Regulation

21 CFR 862.1645

Medical specialty

Clinical Chemistry

Adverse events (MAUDE)

1992: 1 · 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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