510(k) K081495 ยท GKZ Counter, Differential Cell
CELL-DYN EMERALD SYSTEM
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | May 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2019 | Abbott Laboratories Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Terminated |
GKZ | None listed |
| Feb 20, 2019 | Abbott Laboratories CELL-DYN Emerald analyzer, REF 09H39-01.
The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory. Terminated |
GKZ | None listed |
| Apr 19, 2016 | Abbott Laboratories CELL-DYN Emerald Cleaner, product number 09H46-02.
960mL.
IVD;
Hematology:
The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer Terminated |
GKZ | None listed |
| Mar 18, 2011 | Abbott Laboratories Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL
The CE Terminated |
GKZ | None listed |
| Mar 17, 2011 | Abbott Laboratories Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02,
Product is manufactured and distributed by
Abbott Diagnostics Division, Santa Clara. CA
Designed for use on the CELL-DYN Terminated |
GKZ | None listed |
| Feb 10, 2011 | Abbott Laboratories Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System;
List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902;
Product is distributed by
Abbott Dia Terminated |
GKZ | None listed |
| Oct 19, 2009 | Abbott Laboratories CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA.
Automated analyzer intended for in-vitro diagnostic use in the clinical labo Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.