510(k) K110530 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
| Applicant | HORIBA ABX SAS, Montpellier, FR |
| Decision | Substantially Equivalent, Apr 30, 2012 |
| Received | Feb 24, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K110530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933 Open, Classified |
CGX | None listed |
| Mar 5, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Multical.
ABX PENTRA N Control.
ABX PENTRA P Control.
The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two
measuring principals: absorbance and ion selective el Terminated |
JIX | 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.