Source document or public record
FDA 510(k) K201017 — BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
FDA 510(k) index record K201017. Device: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit. Applicant as listed: Geneohm Sciences Canada, Inc. (Bd Life Sciences). Decision date: 2021-10-18.
Source
"device_name": "BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K201017.
Device name: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit. Applicant as listed: Geneohm Sciences Canada, Inc. (Bd Life Sciences).
Decision date: 2021-10-18. Decision wording: Substantially Equivalent.
Product code: PQA. Regulation: 21 CFR 866.3975. 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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