Class Class II

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K251875)

K251875 2025-10-27 Traditional
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Description

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system by Affinity Biosensors, LLC, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251875
Clearance Date2025-10-27
Clearance TypeTraditional
Product CodeSAN
Regulation Number866.1650

Categories

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