Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CareSuperb™ COVID-19 Antigen Home Test

K-Number: K241915 · 2025-01-29

ApplicantAccess Bio, Inc.
Decision Date2025-01-29
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CareSuperb™ COVID-19 Antigen Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio, Inc.. It received FDA 510(k) clearance on 2025-01-29 under 510(k) number K241915. 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 CareSuperb™ COVID-19 Antigen Home Test?

CareSuperb™ COVID-19 Antigen Home Test is a medical device that received FDA 510(k) clearance on 2025-01-29. The listed applicant is Access Bio, Inc.. The 510(k) number is K241915.

When did CareSuperb™ COVID-19 Antigen Home Test receive FDA 510(k) clearance?

CareSuperb™ COVID-19 Antigen Home Test received FDA 510(k) clearance on 2025-01-29, under 510(k) number K241915.

Who is the listed applicant for CareSuperb™ COVID-19 Antigen Home Test?

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

What is the FDA product code for CareSuperb™ COVID-19 Antigen Home Test?

The FDA product code for CareSuperb™ COVID-19 Antigen Home Test is QYT.

Other records listing Access Bio, 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.

K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestK191514CareStart Flu A&B Plus

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.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLC

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.

↑