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FDA 510(k)

GenaCheck COVID-19 Rapid Self-Test

K-Number: K251753 · 2025-09-05

ApplicantGenabio Diagnostics, Inc.
Decision Date2025-09-05
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GenaCheck COVID-19 Rapid Self-Test is the device name listed in this FDA 510(k) record. The listed applicant is Genabio Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K251753. 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 GenaCheck COVID-19 Rapid Self-Test?

GenaCheck COVID-19 Rapid Self-Test is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Genabio Diagnostics, Inc.. The 510(k) number is K251753.

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

GenaCheck COVID-19 Rapid Self-Test received FDA 510(k) clearance on 2025-09-05, under 510(k) number K251753.

Who is the listed applicant for GenaCheck COVID-19 Rapid Self-Test?

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

What is the FDA product code for GenaCheck COVID-19 Rapid Self-Test?

The FDA product code for GenaCheck COVID-19 Rapid Self-Test is QYT.

Other records listing Genabio Diagnostics, 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.

K240545GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

Related Devices (Code: QYT)

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.

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLCK260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLCK251916GenBody COVID-19 Ag Home TestGenbody.Inc.K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLCK243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, 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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