Horiba Abx
Montpellier, FR
Horiba Abx appears in FDA device records in Montpellier, FR. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Horiba Abx between 2005 and 2008. The busiest year on record is 2006, with 6. The most recent is 2008, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 5 |
| 2006 | 6 |
| 2007 | 5 |
| 2008 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | LCP | Substantially Equivalent | |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | CFR | Substantially Equivalent | |
| K071779 | ABX PENTRA URINE CAL | JIX | Substantially Equivalent | |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | CGX | Substantially Equivalent | |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | CDQ | Substantially Equivalent | |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | CGS | Substantially Equivalent | |
| K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL | CIX | Substantially Equivalent | |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | CIC | Substantially Equivalent | |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | JFJ | Substantially Equivalent | |
| K061138 | ABX PENTRA 400 : CRP | DCK | Substantially Equivalent | |
| K060854 | ABX PENTRA 400: LIPOPROTEINS | JIT | Substantially Equivalent | |
| K060325 | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P | CIG | Substantially Equivalent | |
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | CIT | Substantially Equivalent | |
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | CJE | Substantially Equivalent | |
| K053308 | ABX MICROS CRP 200, OPTION IM | GKZ | Substantially Equivalent | |
| K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) | CFR | Substantially Equivalent | |
| K050448 | CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 | GGP | Substantially Equivalent | |
| K050721 | ABX ERYTROL | JPK | Substantially Equivalent | |
| K050719 | ABX PENTRA DX 120: OPTION SPS EVOLUTION | GKZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- LCPAssay, Glycosylated Hemoglobin
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CFRHexokinase, Glucose
- JPKMixture, Hematology Quality Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- GGPTest, Qualitative And Quantitative Factor Deficiency
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Horiba Abx edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Horiba Abx. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain