Documento fuente o registro público
FDA 510(k) K221871 — Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
FDA 510(k) index record K221871. Device: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx. Applicant as listed: Healstone Biotech, Inc.. Decision date: 2022-08-30.
Fuente
"device_name": "Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-30
professional use
FDA 510(k) public index record K221871.
Device name: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx. Applicant as listed: Healstone Biotech, Inc..
Decision date: 2022-08-30. Decision wording: Substantially Equivalent.
Product code: NFT. Regulation: 21 CFR 862.3100. Medical specialty: Clinical Toxicology.
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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