510(k) K200533— binx io CT/NG Assay and binx io CT/NG System

Substantially Equivalent

Binx Health, Inc.

Clearance details

Applicant: Binx Health, Inc.
Product code: Code QEP
Advisory panel: Microbiology
Date received: 2020-03-02
Decision date: 2020-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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