510(k) K964856 ยท GKZ Counter, Differential Cell
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
| Applicant | Caltag Laboratories, Inc., Dowingtown PA, US |
| Decision | Substantially Equivalent, Jan 17, 1997 |
| Received | Dec 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964856
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.