BD GENEOHM VANR ASSAY— 510(k) K102416

Substantially Equivalent

Bd Diagnostics Science

FDA 510(k) clearance K102416 for BD GENEOHM VANR ASSAY, Substantially Equivalent on 2011-10-20. Applicant: Bd Diagnostics Science. Device class: 2.

Clearance details

Applicant: Bd Diagnostics Science
Product code: Code NIJ
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2010-08-24
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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