Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005509212

FEI Number

3005509212

Entity Name

INPECO S.P.A.

City/State/Country

Val della Torre Torino, IT

Establishment Address

Via Givoletto 15, Val della Torre Torino 10040, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INPECO S.p.A. (Owner Number: 9100479)

Owner / Operator Contact Address

via Givoletto 15, Val della Torre, IT-TO 10040, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FlexPath Blox FlexLab, several models Aptio Automation ACCELERATOR a3600 ProTube Aptio Automation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2026-02-09
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-12-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-12-10
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2012-12-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-12-10
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-12-10
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2007-04-17
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2021-10-22

Official Correspondent

Emanuele Bugnone

US Agent Details

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

Related Public Records

Same Entity

INPECO S.p.A.

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
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
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-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

Similar Registrations

Registration Number	Establishment Name	Location
3009963993	AZER SCIENTIFIC, INC.	Morgantown, PA, US
3008399755	SLEE MEDICAL GMBH	Nieder-Olm Rhineland-Palatinate, DE
1000391282	MILESTONE S.P.A.	Sorisole Bergamo, IT
3005787343	CELLPATH LTD	NEWTOWN Powys, GB
3016764932	ZHEJIANG GENE SCIENCE CO., LTD	shaoxing Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005509212. Last updated year: 2026. Please use registration number 3005509212 when referencing this establishment in official correspondence.