Documento fuente o registro público
FDA 510(k) K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
FDA 510(k) index record K243575. Device: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls. Applicant as listed: Biokit, S.A.. Decision date: 2025-02-12.
Fuente
"device_name": "ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
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Automated FDA record verification
2026-10-20
2026-10-25
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FDA 510(k) public index record K243575.
Device name: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls. Applicant as listed: Biokit, S.A..
Decision date: 2025-02-12. Decision wording: Substantially Equivalent.
Product code: MYF. Regulation: 21 CFR 866.3305. 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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