Source document or public record
FDA 510(k) K232643 — Cue COVID-19 Molecular Test
FDA 510(k) index record K232643. Device: Cue COVID-19 Molecular Test. Applicant as listed: Cue Health, Inc.. Decision date: 2023-11-28.
Source
"device_name": "Cue COVID-19 Molecular Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K232643.
Device name: Cue COVID-19 Molecular Test. Applicant as listed: Cue Health, Inc..
Decision date: 2023-11-28. Decision wording: Substantially Equivalent.
Product code: QWB. 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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