KSO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Centrifuge, Blood-Bank For In Vitro Diagnostic Use

Device class

Class I (low risk)

Regulation

21 CFR 864.9275

Medical specialty

Hematology

Adverse events (MAUDE)

1992: 1 · 2003: 8 · 2004: 16 · 2006: 2 · 2007: 3 · 2008: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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