JIO

11 FDA 510(k) clearances · Product code

FDA profile

Official device name

Blood, Occult, Colorimetric, In Urine

Device class

Class II (moderate risk)

Regulation

21 CFR 864.6550

Medical specialty

Hematology

Flags

Third-party review eligible

Adverse events (MAUDE)

2001: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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