ClearanceBrief
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

CodeDeviceRecords
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use4
JQPCalculator/Data Processing Module, For Clinical Use3
JJYMulti-Analyte Controls, All Kinds (Assayed)2
CGXAlkaline Picrate, Colorimetry, Creatinine1
CICCresolphthalein Complexone, Calcium1
CITNadh Oxidation/Nad Reduction, Ast/Sgot1
JGJPhotometric Method, Magnesium1
JGSElectrode, Ion Specific, Sodium1
JIXCalibrator, Multi-Analyte Mixture1
JPKMixture, Hematology Quality Control1
PFTReagents For Molecular Diagnostic Test Systems1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 26, 2018Horiba 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
PFTNone listed
Nov 21, 2017Horiba Instruments, Inc dba Horiba Medical
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
Terminated
JJEK052007
Nov 21, 2017Horiba Instruments, Inc dba Horiba Medical
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Terminated
JJEK052007
Jan 2, 2015Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Terminated
JJEK052007
Sep 24, 2014Horiba 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
JGJK060205
Mar 11, 2014Horiba 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
JQPK053308
Mar 5, 2014Horiba 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
JIXK110530
Feb 3, 2014Horiba 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
JJYK110137
K110530
Jan 31, 2014Horiba 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
JJYK052007
Sep 26, 2013Horiba 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
CICK070249
Apr 18, 2013Horiba 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
JGSK052007
Apr 3, 2013Horiba 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
JQPNone listed
Jan 7, 2013Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Terminated
JQPNone listed
Jan 3, 2013Horiba 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
JJEK103788
Jan 3, 2013Horiba 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
CITK060318
Nov 21, 2012Horiba 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
JPKK843962
K850755
Nov 14, 2012Horiba 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
CGXK072115
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