BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
FDA 510(k) clearance K130470 · decided 2013-04-02
Clearance details
- K-number
- K130470
- Device name
- BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
- Applicant
- Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Decision
- Substantially Equivalent
- Date received
- 2013-02-25
- Decision date
- 2013-04-02
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Quebec, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX Syst recall (Z-0238-2026) | Becton Dickinson & Co. | 2025-10-23 |
| BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916 recall (Z-0590-2025) | Becton Dickinson & Co. | 2024-12-03 |