DEVICE CLASS
Class II
REGULATION
21 CFR 862.3650
MEDICAL SPECIALTY
Clinical Toxicology
REVIEW PANEL
TX
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K252684Medtox Diagnostics, Inc. · 510k2026-01-29
K250741Randox Laboratories Limited · 510k2026-01-23
K253082Lin-Zhi International, Inc. · 510k2026-01-16
K252520Immunalysis Corporation · 510k2025-09-11
K251972Healgen Scientific,, LLC · 510k2025-08-15
K251634Lin-Zhi International, Inc. · 510k2025-06-18
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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