510(k) K982231 ยท GKZ Counter, Differential Cell
STATUSFLOW
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 20, 1998 |
| Received | Jun 25, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2014 | BD Biosciences, Systems & Reagents BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry. Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.