binx health io CT/NG Assay— 510(k) K191352

Substantially Equivalent

Binx Health, Inc.

FDA 510(k) clearance K191352 for binx health io CT/NG Assay, Substantially Equivalent on 2019-08-08. Applicant: Binx Health, Inc.. Device class: 2.

Clearance details

Applicant: Binx Health, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2019-05-20
Decision date: 2019-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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