BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit— 510(k) K201017
Substantially EquivalentGeneohm Sciences Canada, Inc. (Bd Life Sciences)
FDA 510(k) clearance K201017 for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit, Substantially Equivalent on 2021-10-18. Applicant: Geneohm Sciences Canada, Inc. (Bd Life Sciences). Device class: 2.
Clearance details
- Applicant
- Geneohm Sciences Canada, Inc. (Bd Life Sciences)
- Product code
- Code PQA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3975
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quebec, CA
Recent devices under product code PQA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.