FDA Registration
Active
🇨🇭 Switzerland
INPECO SA
Reg #: 3010825766
·
FEI: 3010825766
·
Expires 2026
Products
81
Proprietary Names
9
Establishment Types
2
Classifications
81
Registration Details
- Registration Name
- INPECO SA
- Registration Number
- 3010825766
- FEI Number
- 3010825766
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Torraccia 26
- City
- Novazzano Ticino
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K121012
Owner / Operator
- Firm Name
- Inpeco SA
- Operator Number
- 10047217
- Address
- Via Torraccia, 26
- City
- Novazzano
- State
- Ticino
- Postal Code
- 6883
- Country
- CH
- Correspondent
- Matteo Orlandi
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2014-07-22 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-07-22 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2014-07-22 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2014-07-22 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2014-07-22 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Acid, Uric, Uricase (Oxygen Rate) | JHC | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Radioimmunoassay, Immunoglobulins (G, A, M) | CFQ | Class 2 | Immunology | No | 2021-10-22 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2021-10-22 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2021-10-22 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2021-10-22 |
| Enzyme Immunoassay, N-Acetylprocainamide | LAN | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Colorimetric Method, Cpk Or Isoenzymes | JHY | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Radioimmunoassay, Tobramycin | KLB | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Chromatographic Separation, Cpk Isoenzymes | JHT | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2021-10-22 |
| Enzyme Immunoassay, Lidocaine | KLR | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Colorimetric Method, Lipoproteins | JHM | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2021-10-22 |
| Cyclosporine | MKW | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Procainamide | LAR | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2021-10-22 |
| Test Reagents For Ethyl Alcohol | DMJ | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Acid Phosphatase, Thymolphthale Inmonophosphate | CKE | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2021-10-22 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2021-10-22 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2021-10-22 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2021-10-22 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2021-10-22 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2021-10-22 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2026-02-09 |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | Class 1 | Hematology | No | 2026-04-15 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2020-01-28 |
Proprietary Names
ACCELERATOR a3600
FlexLab, Several Models
Aptio Automation
FlexLab X
Aptio Automation System
FlexPath Blox
ProTube
Rotanta 460 robotic
Urine container, Urin-Monovettes, Salivettes, tubes, Screw caps for container, Feaces container
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device