510(k) K052007 ยท CFR Hexokinase, Glucose
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Jul 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052007
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2017 | Horiba Instruments, Inc dba Horiba Medical 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 Terminated |
JJE | None listed |
| Nov 21, 2017 | Horiba Instruments, Inc dba Horiba Medical 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 Terminated |
JJE | None listed |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorim Terminated |
CFR | None listed |
| Jan 2, 2015 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) Terminated |
JJE | None listed |
| Jan 31, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA N Control, Model No. A11A01653
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. Terminated |
JJY | None listed |
| Apr 18, 2013 | Horiba Instruments, Inc dba Horiba Medical HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below.
Used to measure absorbance and ion electrodes. Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.