CareSuperb COVID-19 Antigen Home Test— 510(k) K241915

Name: FDA 510(k) clearance K241915
Creator: U.S. Food and Drug Administration
Published: 2025-01-29

Substantially Equivalent

Access Bio, Inc.

FDA 510(k) clearance K241915 for CareSuperb COVID-19 Antigen Home Test, Substantially Equivalent on 2025-01-29. Applicant: Access Bio, Inc.. Device class: 2.

Clearance details

Applicant: Access Bio, Inc.
Product code: Code QYT
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2024-07-01
Decision date: 2025-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYT

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K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test2026-06-05
K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test2026-04-13
K251916 — GenBody COVID-19 Ag Home Test2026-03-13
K251595 — COVID-19 Detect Rapid Self -Test2025-10-12
K251753 — GenaCheck COVID-19 Rapid Self-Test2025-09-05

More clearances from Access Bio, Inc.

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K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test2025-08-22
K191514 — CareStart Flu A&B Plus2020-02-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.