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

FDA 510(k)

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

K-Number: K251604 · 2025-08-22

ApplicantAccess Bio, Inc.
Decision Date2025-08-22
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is a medical device manufactured by Access Bio, Inc.. It received FDA 510(k) clearance on 2025-08-22 under approval number K251604. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is a medical device that received FDA 510(k) clearance on 2025-08-22. It is manufactured by Access Bio, Inc.. The 510(k) number is K251604.

When was CareSuperb COVID-19/Flu A&B Antigen Combo Home Test approved by the FDA?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test received FDA 510(k) clearance on 2025-08-22, under approval number K251604.

What company makes CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is manufactured by Access Bio, Inc..

What is the FDA product code for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

The FDA product code for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is SCA.

Other Devices by Access Bio, Inc.

K191514CareStart Flu A&B Plus K241915CareSuperb™ COVID-19 Antigen Home Test

Related Devices (Code: SCA)

DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc. K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc. K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.

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.

↑