BD MAX Vaginal Panel, BD MAX Instrument— 510(k) DEN160001

Name: FDA 510(k) clearance DEN160001
Creator: U.S. Food and Drug Administration
Published: 2016-10-28

Unknown

Geneohm Sciences Canada, Inc. (Bd Diagnostics)

FDA 510(k) clearance DEN160001 for BD MAX Vaginal Panel, BD MAX Instrument, Unknown on 2016-10-28. 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: 2016-01-11
Decision date: 2016-10-28
Decision: Unknown
Clearance type: Direct
Location: Quebec, CA

View on FDA.gov ↗

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