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FDA 510(k)

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

K-Number: K201017 · 2021-10-18

ApplicantGeneohm Sciences Canada, Inc. (Bd Life Sciences)
Decision Date2021-10-18
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is a medical device manufactured by Geneohm Sciences Canada, Inc. (Bd Life Sciences). It received FDA 510(k) clearance on 2021-10-18 under approval number K201017. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Geneohm Sciences Canada, Inc. (Bd Life Sciences). The 510(k) number is K201017.

When was BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit approved by the FDA?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit received FDA 510(k) clearance on 2021-10-18, under approval number K201017.

What company makes BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is manufactured by Geneohm Sciences Canada, Inc. (Bd Life Sciences).

What is the FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

The FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is PQA.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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