510(k) K111860 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
BD MAX GBS ASSAY, BD MAX INSTRUMENT
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Jun 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111860
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | Becton Dickinson & Co. BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:
1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927. Open, Classified |
OZN | None listed |
| Jan 21, 2025 | Becton Dickinson & Co. BD PCR Cartridges used with MAX System. Model Number: 437519 Open, Classified |
NJR | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD MAX System, BD MAX Instrument
Version or Model: 441916
Catalog Number: 441916 Open, Classified |
OZN | None listed |
| Apr 4, 2017 | BD LIFE SCIENCES Software version 4.44A utilized on the BD MAX System Terminated |
NSX | None listed |
| Jul 3, 2013 | Becton Dickinson & Co. BD MAX Instrument, catalog #441916
Product Usage:
The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of targ Terminated |
NJR | None listed |
| Mar 22, 2013 | Becton Dickinson & Co. BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Gro Terminated |
NJR | None listed |
| Jan 22, 2013 | Becton Dickinson & Co. Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument. Terminated |
NJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.