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FDA PRODUCT CODE · CLASS II

SAN — Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

Automated system that performs antimicrobial susceptibility testing using positive blood culture samples

DEVICE CLASS
Class II
REGULATION
21 CFR 866.1650
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K260160bioMerieux, Inc. · 510k2026-07-08
K253316Phast Corp. · 510k2026-06-26
K253573Q-Linea AB · 510k2026-04-15
K251875Affinity Biosensors, LLC · 510k2025-10-27
K241324Affinity Biosensors, LLC · 510k2024-10-23

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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