DEVICE CLASS
Class II
REGULATION
21 CFR 866.1620
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K260842Hardy Diagnostics · 510k2026-05-11
K251337Thermo Fisher Scientific (Oxoid Ltd.) · 510k2025-12-05
K253105Hardy Diagnostics · 510k2025-11-20
K251879Liofilchem · 510k2025-08-12
K250956Hardy Diagnostics · 510k2025-06-26
K250885Liofilchem, Inc. · 510k2025-06-23
K250789Thermo Fisher Scientific (Oxoid Ltd.) · 510k2025-06-12
K250454Hardy Diagnostics · 510k2025-05-15
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.