BD GENEOHM STAPHSR ASSAY— 510(k) K071026

Name: FDA 510(k) clearance K071026
Creator: U.S. Food and Drug Administration
Published: 2007-12-20

Substantially Equivalent

Bd Diagnostics (Geneohm Sciences Canada, Inc)

FDA 510(k) clearance K071026 for BD GENEOHM STAPHSR ASSAY, Substantially Equivalent on 2007-12-20. Applicant: Bd Diagnostics (Geneohm Sciences Canada, Inc). Device class: 2.

Clearance details

Applicant: Bd Diagnostics (Geneohm Sciences Canada, Inc)
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2007-04-11
Decision date: 2007-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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