BD MAX Vaginal Panel— 510(k) K191957

Name: FDA 510(k) clearance K191957
Creator: U.S. Food and Drug Administration
Published: 2019-10-21

Substantially Equivalent

Geneohm Sciences Canada, Inc. (Bd Diagnostics)

FDA 510(k) clearance K191957 for BD MAX Vaginal Panel, Substantially Equivalent on 2019-10-21. Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics). Device class: 2.

Clearance details

Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Product code: Code PQA
Device class: Class 2
Regulation: 21 CFR 866.3975
Advisory panel: Microbiology
Date received: 2019-07-23
Decision date: 2019-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

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