LEF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Stains, Dye Powder

Device class

Class I (low risk)

Regulation

21 CFR 864.1850

Medical specialty

Hematology

Flags

GMP exempt

Adverse events (MAUDE)

2001: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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