510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211815Substantially Equivalent

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

Affinity Biosensors, Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211815 is the FDA 510(k) clearance record for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System, a class II device, cleared for Affinity Biosensors on under FDA product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples). FDA's definition for product code SAN reads: "Automated system that performs antimicrobial susceptibility testing using positive blood culture samples". FDA records list 3 510(k) clearances for Affinity Biosensors, from to . As of , FDA records show no recalls naming K211815.

Clearance record

Decision date
Received
(1,026 days to decision)
Product code
SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Regulation
21 CFR 866.1650
Device class
Class II
Review panel
Microbiology
Applicant
Affinity Biosensors 222 E. Canon Perdido St., Santa Barbara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAN

Trailing 12 months
3 clearances under product code SAN in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260