DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES
Recent clearances
P090015Leica Biosystems · pma2026-06-04
P990081Ventana Medical Systems, Inc. · pma2026-05-15
P980018Agilent Technologies Singapore (International) Pte , Ltd. · pma2026-01-28
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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