BD MAX CDIFF ASSAY, BD MAX INSTRUMENT— 510(k) K130470
Substantially EquivalentGeneohm Sciences Canada, Inc. (Bd Diagnostics)
FDA 510(k) clearance K130470 for BD MAX CDIFF ASSAY, BD MAX INSTRUMENT, Substantially Equivalent on 2013-04-02. Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics). Device class: 2.
Clearance details
- Applicant
- Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quebec, CA
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More clearances from Geneohm Sciences Canada, Inc. (Bd Diagnostics)
view allRecalls naming K130470
K-number listed on FDA's recall record- Z-0238-2026 — BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
- Z-0590-2025 — BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130470.
Data sourced from openFDA. This site is unofficial and independent of the FDA.