DEVICE CLASS
Class I
REGULATION
21 CFR 866.2390
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K242976Medical Wire & Equipment Company (Bath), Ltd. · 510k2025-11-26
K250205Jinan Babio Biotechnology Co., Ltd. · 510k2025-09-22
K242576Hangzhou AllTest Biotech Co., Ltd. · 510k2025-04-04
K232565Copan Italia Spa · 510k2024-10-11
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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