BD MAX GBS ASSAY, BD MAX INSTRUMENT
FDA 510(k) clearance K111860 · decided 2012-02-16
Clearance details
- K-number
- K111860
- Device name
- BD MAX GBS ASSAY, BD MAX INSTRUMENT
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2011-06-30
- Decision date
- 2012-02-16
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- NJR
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- 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 PCR Cartridges used with MAX System. Model Number: 437519 recall (Z-1004-2025) | Becton Dickinson & Co. | 2025-01-21 |
| BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916 recall (Z-0590-2025) | Becton Dickinson & Co. | 2024-12-03 |
| Software version 4.44A utilized on the BD MAX System recall (Z-1864-2017) | BD LIFE SCIENCES | 2017-04-04 |
| BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction w recall (Z-1662-2013) | Becton Dickinson & Co. | 2013-07-03 |
| BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR recall (Z-0976-2013) | Becton Dickinson & Co. | 2013-03-22 |
| Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, recall (Z-0701-2013) | Becton Dickinson & Co. | 2013-01-22 |