Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010825766

FEI Number

3010825766

Entity Name

INPECO SA

City/State/Country

Novazzano Ticino, CH

Establishment Address

Via Torraccia 26, Novazzano Ticino 6883, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Inpeco SA (Owner Number: 10047217)

Owner / Operator Contact Address

Via Torraccia, 26, Novazzano, CH-TI 6883, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACCELERATOR a3600 FlexLab, Several Models Aptio Automation FlexLab X Aptio Automation System FlexPath Blox ProTube Rotanta 460 robotic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-07-22
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-07-22
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-07-22
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-07-22
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-07-22
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-10-22
JHC	Acid, Uric, Uricase (Oxygen Rate)	Clinical Chemistry	Class 1	862.1775	2021-10-22
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2021-10-22
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2021-10-22
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2021-10-22
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2021-10-22
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2021-10-22
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2021-10-22
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2021-10-22
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2021-10-22
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2021-10-22
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2021-10-22
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2021-10-22
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2021-10-22
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2021-10-22
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2021-10-22
KLB	Radioimmunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2021-10-22
JHT	Chromatographic Separation, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2021-10-22
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2021-10-22
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2021-10-22
KLR	Enzyme Immunoassay, Lidocaine	Clinical Toxicology	Class 2	862.3555	2021-10-22
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2021-10-22
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2021-10-22
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2021-10-22
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2021-10-22
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2021-10-22
JHM	Colorimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2021-10-22
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2021-10-22
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2021-10-22
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2021-10-22
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2021-10-22
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2021-10-22
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2021-10-22
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2021-10-22
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2021-10-22
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2021-10-22
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2021-10-22
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2021-10-22
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2021-10-22
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2021-10-22
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2021-10-22
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2021-10-22
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2021-10-22
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2021-10-22
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2021-10-22
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2021-10-22
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2021-10-22
DMJ	Test Reagents For Ethyl Alcohol	Clinical Toxicology	Class 2	862.3040	2021-10-22
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2021-10-22
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2021-10-22
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2021-10-22
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2021-10-22
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2021-10-22
CKE	Acid Phosphatase, Thymolphthale Inmonophosphate	Clinical Chemistry	Class 2	862.1020	2021-10-22
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2021-10-22
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2021-10-22
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2021-10-22
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2021-10-22
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2021-10-22
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2021-10-22
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2021-10-22
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2021-10-22
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2021-10-22
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2021-10-22
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2021-10-22
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2021-10-22
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2021-10-22
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2021-10-22
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2021-10-22
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2021-10-22
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2021-10-22
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2021-10-22
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2021-10-22
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2021-10-22
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2021-10-22
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2021-10-22
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2026-02-09
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2018-11-06
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2026-04-15

Official Correspondent

Matteo Orlandi

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

Inpeco SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010825766. Last updated year: 2026. Please use registration number 3010825766 when referencing this establishment in official correspondence.