510(k) K010953 ยท GKZ Counter, Differential Cell
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Mar 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2006 | Abbott Laboratories CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer Terminated |
GKZ | None listed |
| Mar 13, 2003 | Abbott Laboratories Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT
Model/List Number 01H73-01 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.