510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SANClass II

Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

21 CFR 866.1650 / Microbiology
FDA source (opens on fda.gov)

SAN is the FDA product code for Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, a class II device type, regulated under 21 CFR 866.1650. FDA's definition for this code reads: "Automated system that performs antimicrobial susceptibility testing using positive blood culture samples". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAN
Device name
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
FDA definition
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Regulation
21 CFR 866.1650
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code SAN

By decision year
8 clearances under product code SAN with a decision year between 2024 and 2026, 2024 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code SAN by decision year
YearClearances
20244
20251
20263

Applicants with the most clearances

Product code SAN
Applicants holding the most 510(k) clearances under product code SAN
ApplicantClearances
Affinity Biosensors3
Q-linea AB2
Phast Corp.1
Specific Diagnostics1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code