510(k) K962768 ยท GKZ Counter, Differential Cell
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
| Applicant | Coulter Corp., Miami FL, US |
| Decision | Substantially Equivalent, Jan 6, 1997 |
| Received | Jun 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962768
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.