Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681753

FEI Number

3000303338

Entity Name

SENTINEL CH. SPA

City/State/Country

MILANO, IT

Establishment Address

VIA ROBERT KOCH, 2, MILANO 20152, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SENTINEL CH. SpA (Owner Number: 9025279)

Owner / Operator Contact Address

Via Robert Koch, 2, Milan, IT-MI 20152, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083602

PMA Number

N/A

All Registered Proprietary Names

UIBC UIBC LIQUID PLASMAPROTEINS CAL 3X Alinity c UIBC Reagent Kit Lambda Light Chains Alinity c Ceruloplasmin Reagent Kit Ceruloplasmin Sentinel Lipase Liquid Lipase NG Lipase NG OC Reagent Kit PANCREATIC AMYLASE Plasmaproteins Cal 3x ACE Control Set Lp(a) Ultra ColoHealth Cystatin C CERULOPLASMIN Alinity c UIBC Calibrator Kit Lipase NG OC Cal Lp(a) Cal Set ACE Calibrator Cystatin C Calibrators Lipase NG Cal AMMONIA CONTROLS Alinity c Ammonia Ultra Reagent Kit AMMONIA ULTRA ACE Liquid ACE Reagent CRP VARIO CRP CALIBRATOR SET CRP CALIBRATOR HS Alinity c CRP Vario HS Control Kit CRP CONTROL HS CRP CALIBRATOR WR Multigent Lithium Assay Alinity c Lithium Reagent Kit Alinity c Ammonia Controls Lipase NG OC CTRL 2 Lipase NG OC CTRL 1 Lp(a) Control Set ACE Control Cystatin C Controls CRP Vario Alinity c CRP Vario Reagent Kit Creatinine (Enzymatic) Alinity c Creatinine (Enzymatic) Reagent Kit ACE Calibrator ARCHITECT c ACE Assay File Alinity c ACE Assay File CKMB UDR Alinity c Plasmaproteins Cal 3x Kit Alinity c Clinical Chemistry Calibrator Kit Plasmaproteins Cal 3x Clin Chem Cal Alinity c CRP Vario Wide Range Calibrator Kit Alinity c CRP Vario High Sensitivity Calibrator Kit Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit Kappa Light Chains

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQF	Bathophenanthroline, Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2006-03-16
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2005-11-17
JQF	Bathophenanthroline, Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2018-08-22
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2009-09-17
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2018-08-22
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2014-01-30
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2006-03-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-04-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-03-22
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2024-01-24
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2025-08-20
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2025-07-04
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2005-11-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-09-25
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2016-07-20
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2006-03-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-03-16
KQN	Radioassay, Angiotensin Converting Enzyme	Clinical Chemistry	Class 2	862.1090	2016-03-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2005-11-17
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2005-11-17
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2005-11-17
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Clinical Toxicology	Class 2	862.3560	2007-11-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-07-04
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2018-10-31
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-07-29
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-03-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-03-07
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2011-08-24
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-07-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-01-30
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-12-23
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2009-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

Robert McNamee Business: Diagnostic Oncology CRO, LLC Email: Rmcnamee@dxocro.com Phone: (203) 5989105

Related Public Records

Same Entity

SENTINEL CH. SpA

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
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K191454	Siemens Healthcare Diagnostics, Inc.	Atellica CH Amylase_2 (AMY_2)	2019-07-30
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681753. Last updated year: 2026. Please use registration number 9681753 when referencing this establishment in official correspondence.