510(k) K072115 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | Aug 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2012 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.
The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for t Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.