510(k) K110137 ยท JFY Enzymatic Method, Creatinine
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
| Applicant | HORIBA ABX SAS, Montpellier, FR |
| Decision | Substantially Equivalent, Aug 10, 2011 |
| Received | Jan 18, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K110137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method Terminated |
CGX | None listed |
| Feb 3, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Urine Control L/H.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control
consisting of liquid solutions prepared from human urine with chemical additives and
mater Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.