Documento fuente o registro público
FDA 510(k) K262299 — Instant-View® hCG Combo II Cassette Test
FDA 510(k) index record K262299. Device: Instant-View® hCG Combo II Cassette Test. Applicant as listed: Alfa Scientific Designs, Inc.. Decision date: 2026-09-22.
Fuente
"device_name": "Instant-View® hCG Combo II Cassette Test"
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K262299.
Device name: Instant-View® hCG Combo II Cassette Test. Applicant as listed: Alfa Scientific Designs, Inc..
Decision date: 2026-09-22. Decision wording: Substantially Equivalent.
Product code: JHI. Regulation: 21 CFR 862.1155. Medical specialty: Clinical Chemistry.
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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