510(k) K933486 ยท GKZ Counter, Differential Cell
FASCOUNT SYSTME
| Applicant | Becton Dickinson Immunocytometry Systems, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 9, 1994 |
| Received | Jul 19, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2010 | BD Biosciences, Systems & Reagents BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166,
Product is manufactured and distributed by BD Biosciences, San Jose, CA
The reagents are for in v Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.