Company ยท US
Horiba Instruments Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1985. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
| OUG | Medical Device Data System | 1 |
| REM | Spectroscopy Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 4, 1985 | K853405 | ELECTROLYTE ANALYZER SERA-252 Horiba Instruments, Inc. | CHL |
| Sep 3, 1985 | K853356 | SERA-210 ELECTROLYTE ANALYZER Horiba Instruments, Inc. | CEM |
| Jan 8, 1985 | K844806 | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 Horiba Instruments, Inc. | CEM |
| Jun 22, 1984 | K841424 | ELECTROLYTE ANALYZER SERA-210 Horiba Instruments, Inc. | JGS |
| Apr 6, 1984 | K841441 | SERA-250 Horiba Instruments, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2024 | Horiba Instruments Incorporated HORIBA custom configured fluorescence instrument, modular Fluorolog-QM Open, Classified |
REM | None listed |
| Oct 30, 2018 | Horiba Instruments Incorporated Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 Terminated |
CHI | None listed |
| Feb 19, 2016 | Horiba Instruments Inc Pentra C400 (version 1.1.2 or lower)
The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedu Terminated |
JJE | None listed |
| Feb 19, 2016 | Horiba Instruments Inc ABX Pentra 400 (version 5.0.8 or lower)
The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical proc Terminated |
JJE | None listed |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric ac Terminated |
KNK | K081276 |
| 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 | K060854 |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Lactic Acid CP ref. A11A01721
reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the Terminated |
KHP | 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 | K052007 |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method Terminated |
CGX | K110137 |
| 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 | K060854 |
| Dec 23, 2014 | Horiba Instruments Inc Lite DM (Lite Data Manager)
Software Version(s): Versions 2.0.0.19 and lower
Product Model #: D00A00224D
The Lite DM (Lite Data Manager) is a software application developed by HORIBA
Medical intended Terminated |
OUG | None listed |