Source document or public record
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.
Source
"device_name": "ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls"
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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2026-10-20
2026-10-20
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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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