510(k) K970836 ยท GKZ Counter, Differential Cell
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
| Applicant | Becton Dickinson Immunocytometry Systems, San Jose CA, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Feb 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2016 | Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes:
Catalog number: 340334
Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood. Terminated |
GKZ | None listed |
| Mar 31, 2016 | Becton, Dickinson and Company, BD Biosciences BD Trucount Absolute Counting Tubes:
Model number: 340334
IVD;
BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.