510(k) K974651 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
ABBOTT AXSYM SYSTEM
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 12, 1998 |
| Received | Dec 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2009 | Abbott Laboratories AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09.
To be used only for cleaning and inhibition of fou Terminated |
JJE | None listed |
| Nov 17, 2006 | Abbott Diagnostic International, Ltd. Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 Terminated |
JJE | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas Terminated |
JJE | None listed |
| Dec 25, 2003 | Abbott Laboratories, Inc The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas Terminated |
JJE | None listed |
| Jan 11, 2003 | Abbott Laboratories, Inc AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.