Company
Horiba Instruments, Inc dba Horiba Medical
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 4 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 3 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2018 | Horiba Instruments, Inc dba Horiba Medical ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563
The device is intended for use in conjunction with certain materials to measure a variety of analytes. Terminated |
PFT | 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 | K052007 |
| 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 | K052007 |
| 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 | K052007 |
| Sep 24, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646
Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination o Terminated |
JGJ | K060205 |
| Mar 11, 2014 | Horiba Instruments, Inc dba Horiba Medical Device Name: ABX PENTRA ML
Model/Part #(s): A11A01652
Lot/Serial #(s): N/A
Software Version(s): All versions are subject to this correction.
Product Usage:
The ABX PENTRA ML is a software data manag Terminated |
JQP | K053308 |
| 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 | K110530 |
| 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 | K110137 K110530 |
| 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 | K052007 |
| Sep 26, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Calcium CP Reagent, Model # A11A01633
Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone minera Terminated |
CIC | K070249 |
| 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 | K052007 |
| Apr 3, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX Micros IM2, Part# M60CSB110EN04 and D00A00202
The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The I Terminated |
JQP | None listed |
| Jan 7, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Terminated |
JQP | None listed |
| Jan 3, 2013 | Horiba Instruments, Inc dba Horiba Medical PENTRA C200, Part Number: A11A01629.
The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro d Terminated |
JJE | K103788 |
| Jan 3, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA AST CP, Part Number: A11A01629.
The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by col Terminated |
CIT | K060318 |
| Nov 21, 2012 | Horiba Instruments, Inc dba Horiba Medical Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High).
Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accu Terminated |
JPK | K843962 K850755 |
| 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 | K072115 |