← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
JWY — Manual Antimicrobial Susceptibility Test Systems
DEVICE CLASS
Class II
REGULATION
21 CFR 866.1640
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
21
510(K)/PMA CLEARANCES
510k: 21
0
RECALL ENTRIES
Recent clearances
K260447bioMérieux SA · 510k2026-04-21
K260696Liofilchem s.r.l. · 510k2026-04-17
K252114Liofilchem s.r.l. · 510k2025-10-02
K252062Thermo Fisher Scientific · 510k2025-09-25
K250575Thermo Fisher Scientific · 510k2025-09-05
K252014Thermo Fisher Scientific · 510k2025-08-28
K251580Liofilchem s.r.l. · 510k2025-08-20
K250990Thermo Fisher Scientific · 510k2025-06-30
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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