510(k) K081213 ยท GKZ Counter, Differential Cell
BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
| Applicant | Bd Biosciences, San Jose CA, US |
| Decision | Substantially Equivalent, Aug 14, 2008 |
| Received | Apr 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2015 | BD Biosciences, Systems & Reagents BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway Terminated |
GKZ | None listed |
| 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.