510(k) K090967 ยท GKZ Counter, Differential Cell
BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
| Applicant | Bd Biosciences, San Jose CA, US |
| Decision | Substantially Equivalent, Jul 31, 2009 |
| Received | Apr 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2022 | Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, Open, Classified |
GKZ | None listed |
| Nov 3, 2022 | Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, Open, Classified |
GKZ | None listed |
| Nov 3, 2022 | Becton, Dickinson and Company, BD Biosciences BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute coun Open, Classified |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.