510(k) K931368 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
MICROTAINER BRAND TUBE WITH EDTA
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Sep 28, 1993 |
| Received | Mar 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2019 | Becton Dickinson & Company BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975
Product Usage:
The Microtainer Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagu Terminated |
JKA | None listed |
| Oct 28, 2004 | Becton Dickinson & Company BD Vacutainer Microtainer Serum tubes (with or without gel). Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.