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FDA 510(k)

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

K-Number: K200533 · 2020-04-27

ApplicantBinx Health, Inc.
Decision Date2020-04-27
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

binx io CT/NG Assay and binx io CT/NG System is the device name listed in this FDA 510(k) record. The listed applicant is Binx Health, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200533. 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 io CT/NG Assay and binx io CT/NG System?

binx io CT/NG Assay and binx io CT/NG System is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Binx Health, Inc.. The 510(k) number is K200533.

When did binx io CT/NG Assay and binx io CT/NG System receive FDA 510(k) clearance?

binx io CT/NG Assay and binx io CT/NG System received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200533.

Who is the listed applicant for binx io CT/NG Assay and binx io CT/NG System?

The FDA 510(k) record lists Binx Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Binx Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191352binx health io CT/NG Assay

Related Devices (Code: QEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.

Official Source

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

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