Source document or public record
FDA 510(k) K241915 — CareSuperb COVID-19 Antigen Home Test
FDA 510(k) index record K241915. Device: CareSuperb COVID-19 Antigen Home Test. Applicant as listed: Access Bio, Inc.. Decision date: 2025-01-29.
Source
"device_name": "CareSuperb COVID-19 Antigen Home Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K241915.
Device name: CareSuperb COVID-19 Antigen Home Test. Applicant as listed: Access Bio, Inc..
Decision date: 2025-01-29. Decision wording: Substantially Equivalent.
Product code: QYT. Regulation: 21 CFR 866.3984. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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