BD MAX STAPHSR ASSAY, INSTRUMENT— 510(k) K132822

Substantially Equivalent

Geneohm Sciences Canada, Inc. (Bd Diagnostics)

FDA 510(k) clearance K132822 for BD MAX STAPHSR ASSAY, INSTRUMENT, Substantially Equivalent on 2013-11-26. Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics).

Clearance details

Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Product code: Code NQX
Advisory panel: Microbiology
Date received: 2013-09-09
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

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