510(k) K981706 ยท JIX Calibrator, Multi-Analyte Mixture
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jul 9, 1998 |
| Received | May 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2009 | Abbott Laboratories Inc. Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200
For use in the calibration of the Iron and Magnesium assays. Terminated |
JIX | None listed |
| Aug 10, 2007 | Abbott Laboratories Inc. Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064 Terminated |
JIX | None listed |
| Feb 14, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Multiconstituent Calibrator---
List number: lE65-02 Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.