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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201017
510(k) Type
Traditional
Applicant
GeneOhm Sciences Canada, Inc. (BD Life Sciences)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
10/18/2021
Days to Decision
549 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201017
510(k) Type
Traditional
Applicant
GeneOhm Sciences Canada, Inc. (BD Life Sciences)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
10/18/2021
Days to Decision
549 days
Submission Type
Summary