KQG

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

Instrument, Coagulation

Device class

Class II (moderate risk)

Regulation

21 CFR 864.5400

Medical specialty

Hematology

Flags

Third-party review eligible

Adverse events (MAUDE)

1995: 3 · 1996: 3 · 1997: 6 · 2001: 2 · 2009: 8 · 2010: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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