BD MAX MRSA ASSAY, BD MAX INSTRUMENT
FDA 510(k) clearance K120138 · decided 2012-07-05
Clearance details
- K-number
- K120138
- Device name
- BD MAX MRSA ASSAY, BD MAX INSTRUMENT
- Applicant
- Bd Diagnostics (Geneohm Sciences Canada, Inc)
- Decision
- Substantially Equivalent
- Date received
- 2012-01-17
- Decision date
- 2012-07-05
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- NQX
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| cobas MRSA/SA Test (K142721) | Roche Molecular Systems, Inc. | 2014-12-17 |
| BD MAX MRSA XT, BD MAX INSTRUMENT (K133605) | Geneohm Sciences Canada, Inc. | 2013-12-20 |
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| MRSA/SA ELITE MGB (K112937) | Elitech | 2012-06-01 |
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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 |
| The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic tes recall (Z-2618-2014) | Becton Dickinson & Co. | 2014-09-10 |