510(k) K900802 ยท GKZ Counter, Differential Cell
ANTI-HUMAN LEU-3A (CD4) FITC
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, May 15, 1990 |
| Received | Feb 20, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900802
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2015 | Becton, Dickinson and Company, BD Biosciences CD4 (SK3), FITC;
Contains CD4 FITC with gelatin and 0.1% sodium Azide.
Catalog number 340133
in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell s Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.