BD MAX Vaginal Panel
K-Number: K191957 · 2019-10-21
Decision Date2019-10-21
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BD MAX Vaginal Panel is a medical device manufactured by Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2019-10-21 under approval number K191957. 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 Vaginal Panel is a medical device that received FDA 510(k) clearance on 2019-10-21. It is manufactured by Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K191957.
When was BD MAX Vaginal Panel approved by the FDA?
BD MAX Vaginal Panel received FDA 510(k) clearance on 2019-10-21, under approval number K191957.
What company makes BD MAX Vaginal Panel?
BD MAX Vaginal Panel is manufactured by Geneohm Sciences Canada, Inc. (Bd Diagnostics).
What is the FDA product code for BD MAX Vaginal Panel?
The FDA product code for BD MAX Vaginal Panel is PQA.
Other Devices by Geneohm Sciences Canada, Inc. (Bd Diagnostics)
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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.