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FDA 510(k)

Heal-Check Rapid COVID-19 Antigen Self-Test

K-Number: K260095 · 2026-04-13

ApplicantHealgen Scientific,, LLC
Decision Date2026-04-13
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Heal-Check Rapid COVID-19 Antigen Self-Test is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2026-04-13 under approval number K260095. 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 Heal-Check Rapid COVID-19 Antigen Self-Test?

Heal-Check Rapid COVID-19 Antigen Self-Test is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K260095.

When was Heal-Check Rapid COVID-19 Antigen Self-Test approved by the FDA?

Heal-Check Rapid COVID-19 Antigen Self-Test received FDA 510(k) clearance on 2026-04-13, under approval number K260095.

What company makes Heal-Check Rapid COVID-19 Antigen Self-Test?

Heal-Check Rapid COVID-19 Antigen Self-Test is manufactured by Healgen Scientific,, LLC.

What is the FDA product code for Heal-Check Rapid COVID-19 Antigen Self-Test?

The FDA product code for Heal-Check Rapid COVID-19 Antigen Self-Test is QYT.

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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. K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc. K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc. K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc. K231795QuickVue COVID-19 TestQuidel Corporation

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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