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FDA 510(k)

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

K-Number: K240728 · 2024-06-21

ApplicantCorDx, Inc.
Decision Date2024-06-21
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is a medical device manufactured by CorDx, Inc.. It received FDA 510(k) clearance on 2024-06-21 under approval number K240728. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by CorDx, Inc.. The 510(k) number is K240728.

When was CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test approved by the FDA?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test received FDA 510(k) clearance on 2024-06-21, under approval number K240728.

What company makes CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is manufactured by CorDx, Inc..

What is the FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

The FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is QYT.

Related Devices (Code: QYT)

K230828Flowflex COVID-19 Antigen Home TestACON Laboratories, Inc. K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co., Ltd. K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc. K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc. K231795QuickVue COVID-19 TestQuidel Corporation K251595COVID-19 Detect Rapid Self -TestInBios International, 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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