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Data / Medical devices / Italy / Sentinel CH. SPA

Sentinel CH. SPA: FDA-registered device maker in Milano, Italy, 24 510(k) clearances

Sentinel CH. SPA is registered with the FDA (registration 9681753) in Milano, Italy. It lists 27 device types. The FDA files 24 510(k) clearances under its listings, the newest dated May 16, 2025. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Sentinel CH. SPA
FDA registration number
9681753
FEI number
3000303338
Address
Via Robert Koch, 2, Milano, Italy, 20152
Owner or operator
SENTINEL CH. SpA (9025279)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
November 17, 2005
Registered through
2026
Brand names listed
ACE Calibrator, ACE Control, ACE Control Set, ACE Liquid, ACE Reagent, AMMONIA CONTROLS, AMMONIA ULTRA, ARCHITECT c ACE Assay File and more

Devices it lists

DeviceProduct codeClassRoleSource
Acetylcholine Chloride, Specific Reagent For Pseudo CholinesteraseDLI1Contract manufacturer, Manufactureraccessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Contract manufacturer, Manufactureraccessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, LithiumNDW2Manufactureraccessdata.fda.gov
Bathophenanthroline, Iron Binding CapacityJQF1Manufactureraccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Manufactureraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Contract manufacturer, Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrator, PrimaryJIS2Contract manufacturer, Manufactureraccessdata.fda.gov
Calibrator, SecondaryJIT2Manufactureraccessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And ControlNQD2Manufactureraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Manufactureraccessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or IsoenzymesJHS2Manufactureraccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Manufactureraccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Manufactureraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Contract manufacturer, Manufactureraccessdata.fda.gov
Indirect Copper Assay, CeruloplasminJFR2Manufactureraccessdata.fda.gov
Kappa, Antigen, Antiserum, ControlDFH2Manufactureraccessdata.fda.gov
Lambda, Antigen, Antiserum, ControlDEH2Manufactureraccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Manufactureraccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufactureraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Manufactureraccessdata.fda.gov
Radioassay, Angiotensin Converting EnzymeKQN2Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin DetectionPHP3Contract manufactureraccessdata.fda.gov
Test, Cystatin CNDY2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 16, 2025K242585Cystatin CNDYSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
December 22, 2022K211058Lp(a) UltraDFCSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
December 19, 2019K193001Albumin BCPCJWSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
November 8, 2019K192118CRP VarioDCKSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
September 27, 2018K173833CRP VarioNQDSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
July 28, 2014K141728ACE CALIBRATORJITSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
August 19, 2011K102706CKMB UDR ASSAYJHSSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
September 3, 2009K083602KAPPA LIGHT CHAINSDFHSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
June 22, 2009K083601LAMBDA LIGHT CHAINSDEHSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
June 25, 2008K081533SENTINEL PLASMAPROTEINS CAL 3XJIXSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
June 19, 2008K073634MULTIGENT CREATININE (ENZYMATIC) ASSAYJFYSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
August 2, 2007K070987SENTINEL LITHIUM ASSAYNDWSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
May 23, 2007K070971MODIFICATION TO SENTINEL CLIN CHEM CALJIXSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
January 26, 2006K051447SENTINEL PANCREATIC AMYLASEJFJSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
November 25, 2005K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYJIFSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
November 17, 2005K051111SENTINEL UIBC LIQUIDJQFSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
October 21, 2005K051456SENTINEL CERULOPLASMINJFRSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
August 25, 2005K051115SENTINEL IRON LIQUIDJIYSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
August 8, 2005K050836CRP DIAGNOSTIC ASSAYDCKSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
July 25, 2005K051457SENTINEL PLASMAPROTEINS CAL 3XJIXSubstantially EquivalentSentinel Ch. Srlaccessdata.fda.gov
November 20, 2003K033501MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)JIXSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
July 6, 1998K981800SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606HIHSubstantially EquivalentEqual Diagnostics, Inc.accessdata.fda.gov
July 19, 1996K961179SENTINEL LIPASE LIQUID MODEL 17.401BCHISubstantially EquivalentEqual Diagnostics, Inc.accessdata.fda.gov
April 20, 1994K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLJJXSubstantially EquivalentAnalytical Control Systems, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 29, 202393298Class IIOngoingIRON assay, Reference Numbers 6K95-41 and 6K95-30A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abaccessdata.fda.gov
July 29, 202188680Class IIITerminatedAlinity 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 analCalibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.accessdata.fda.gov
April 30, 202188040Class IIIOngoingACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.accessdata.fda.gov
June 28, 201983516Class IITerminatedMULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient resultsaccessdata.fda.gov
May 22, 201777405Class IITerminatedMULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medicReagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.accessdata.fda.gov
September 22, 201572311Class IITerminatedSentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.accessdata.fda.gov

Compare with other makers

Updated May 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.