510(k) K842218 ยท LIZ Assay, T Lymphocyte Surface Marker
ANTI-LEU-4 FITC LYSIN C BUFFER
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Dec 27, 1984 |
| Received | Jun 4, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2015 | Becton, Dickinson and Company, BD Biosciences BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542
Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic. Terminated |
LIZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.