510(k) K974883 ยท MDB System, Blood Culturing
BACTEC MGIT 960 SYSTEM
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Cockeysville MD, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Dec 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2013 | Becton Dickinson & Co. BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part
Product Usage:
The Mycobacteria Growth Indicator Tube supplemented with Bactec Terminated |
MDB | None listed |
| Jul 28, 2011 | Becton Dickinson & Co. BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A.
Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.