GHM

18 FDA 510(k) clearances · Product code

FDA profile

Official device name

Test, Sickle Cell

Device class

Class II (moderate risk)

Regulation

21 CFR 864.7825

Medical specialty

Hematology

Flags

Third-party review eligible

Adverse events (MAUDE)

1996: 5 · 2001: 2 · 2003: 10 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free