Name: Predicase
Price: 199 USD

K-number	K251875
Device name	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Applicant	Affinity Biosensors, LLC
Product code	SAN
Device class	Class II
Decision date	Oct 27, 2025
Decision	Substantially Equivalent
Regulation	866.1650

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.