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FDA 510(k)

binx health io CT/NG Assay

K-Number: K191352 · 2019-08-08

ApplicantBinx Health, Inc.
Decision Date2019-08-08
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

binx health io CT/NG Assay is a medical device manufactured by Binx Health, Inc.. It received FDA 510(k) clearance on 2019-08-08 under approval number K191352. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the binx health io CT/NG Assay?

binx health io CT/NG Assay is a medical device that received FDA 510(k) clearance on 2019-08-08. It is manufactured by Binx Health, Inc.. The 510(k) number is K191352.

When was binx health io CT/NG Assay approved by the FDA?

binx health io CT/NG Assay received FDA 510(k) clearance on 2019-08-08, under approval number K191352.

What company makes binx health io CT/NG Assay?

binx health io CT/NG Assay is manufactured by Binx Health, Inc..

What is the FDA product code for binx health io CT/NG Assay?

The FDA product code for binx health io CT/NG Assay is QEP.

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K200533binx io CT/NG Assay and binx io CT/NG System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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