Source document or public record
FDA 510(k) K201403 — NATtrol BD MAX Vaginal Panel External Controls
FDA 510(k) index record K201403. Device: NATtrol BD MAX Vaginal Panel External Controls. Applicant as listed: Zeptometrix. Decision date: 2022-02-02.
Source
"device_name": "NATtrol BD MAX Vaginal Panel External 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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K201403.
Device name: NATtrol BD MAX Vaginal Panel External Controls. Applicant as listed: Zeptometrix.
Decision date: 2022-02-02. Decision wording: Substantially Equivalent.
Product code: PMN. Regulation: 21 CFR 866.3920. 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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