FDA 510(k)

Heal-Check Rapid COVID-19 Antigen Self-Test

N.º K: K260095 · 2026-04-13

Fecha de decisión2026-04-13

Código de productoQYT

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Heal-Check Rapid COVID-19 Antigen Self-Test is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K260095. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K260095.

When did Heal-Check Rapid COVID-19 Antigen Self-Test receive FDA 510(k) clearance?

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

Who is the listed applicant for Heal-Check Rapid COVID-19 Antigen Self-Test?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

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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K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC K251916GenBody COVID-19 Ag Home TestGenbody.Inc.K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLC K243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.

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