510(k) K211815— LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

Substantially Equivalent

Affinity Biosensors

Clearance details

Applicant: Affinity Biosensors
Product code: Code SAN
Advisory panel: Microbiology
Date received: 2021-06-11
Decision date: 2024-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

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