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

Substantially Equivalent

Affinity Biosensors, LLC

Clearance details

Applicant: Affinity Biosensors, LLC
Product code: Code SAN
Advisory panel: Microbiology
Date received: 2025-06-18
Decision date: 2025-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

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