510(k) K060854 ยท JIT Calibrator, Secondary
ABX PENTRA 400: LIPOPROTEINS
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | Mar 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2016 | Horiba Instruments Inc The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders re Terminated |
CHH | None listed |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.