LCI

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Automated Radioimmunoassay Systems, For Clinical Use

Device class

Class I (low risk)

Regulation

21 CFR 862.2050

Medical specialty

Clinical Chemistry

Flags

Third-party review eligible

Adverse events (MAUDE)

1999: 3 · 2000: 5 · 2001: 4 · 2002: 2 · 2005: 7 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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