Medicon Hellas SA
GERAKAS Attiki, GR
MEDICON HELLAS SA appears in FDA device records in GERAKAS Attiki, GR. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Medicon Hellas SA between 2006 and 2024. The busiest year on record is 2006, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | CHH | Substantially Equivalent | |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin | CIX | Substantially Equivalent | |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | DBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006716639 | 3006716639 | MEDICON HELLAS SA | MELITONA 5-7, GERAKAS Attiki 15344 GR | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTZAntisera, All Groups, Streptococcus Spp.
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DBFFerritin, Antigen, Antiserum, Control
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CFRHexokinase, Glucose
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- MRRSystem, Test, Low Density, Lipoprotein
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain