JFM

11 FDA 510(k) clearances · Product code

FDA profile

Official device name

Enzymatic Method, Bilirubin

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1110

Medical specialty

Clinical Chemistry

Flags

Third-party review eligible

Adverse events (MAUDE)

1999: 1 · 2007: 8 · 2010: 7 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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