FDA Product Code SAN: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples
Leading manufacturers include Q-Linea AB, Affinity Biosensors, LLC and Affinity Biosensors.
FDA 510(k) Cleared Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Devices (Product Code SAN)
About Product Code SAN - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code SAN since 2024, with 6 receiving FDA clearance (average review time: 438 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under SAN have taken an average of 229 days to reach a decision - down from 856 days historically, suggesting improved FDA processing for this classification.
SAN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →