← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

DEVICE CLASS
Class II
REGULATION
21 CFR 866.1645
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K260282bioMerieux, Inc. · 510k2026-04-15
K260281BIOMERIEUX · 510k2026-03-26
K251579bioMerieux, Inc. · 510k2025-08-21
K251713Becton, Dickinson and Company · 510k2025-08-08
K250447Becton, Dickinson and Company · 510k2025-05-19
K234012bioMerieux, Inc. · 510k2025-03-14
K250344Becton, Dickinson and Company · 510k2025-03-06

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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