510(k) K041071 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
| Applicant | Becton, Dickinson & CO, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, May 14, 2004 |
| Received | Apr 26, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2014 | Fresenius Medical Care Holdings, Inc. BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML)
Part Number: 363083
Part Number: FMC 87-8380-1
Single use tube used to collect, separate, transport or process blood specimens for labora Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.