Company ยท IT
SENTINEL CH. SpA
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2025. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| JIY | Photometric Method, Iron (Non-Heme) | 3 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| JFY | Enzymatic Method, Creatinine | 2 |
| JIF | Enzymatic Method, Ammonia | 2 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| DEH | Lambda, Antigen, Antiserum, Control | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 1 |
| DIH | Colorimetry, Cholinesterase | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JFR | Indirect Copper Assay, Ceruloplasmin | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| JIS | Calibrator, Primary | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JQF | Bathophenanthroline, Iron Binding Capacity | 1 |
| NDY | Test, Cystatin C | 1 |
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2025 | K242585 | Cystatin C SENTINEL CH. SpA, IT | NDY |
| Dec 22, 2022 | K211058 | Lp(a) Ultra SENTINEL CH. SpA, IT | DFC |
| Dec 19, 2019 | K193001 | Albumin BCP SENTINEL CH. SpA, IT | CJW |
| Nov 8, 2019 | K192118 | CRP Vario SENTINEL CH. SpA, IT | DCK |
| Sep 27, 2018 | K173833 | CRP Vario SENTINEL CH. SpA, IT | NQD |
| Jul 28, 2014 | K141728 | ACE CALIBRATOR SENTINEL CH. SpA, IT | JIT |
| Aug 19, 2011 | K102706 | CKMB UDR ASSAY SENTINEL CH. SpA, IT | JHS |
| Sep 3, 2009 | K083602 | KAPPA LIGHT CHAINS SENTINEL CH. SpA, IT | DFH |
| Jun 22, 2009 | K083601 | LAMBDA LIGHT CHAINS SENTINEL CH. SpA, IT | DEH |
| Jun 25, 2008 | K081533 | SENTINEL PLASMAPROTEINS CAL 3X SENTINEL CH. SpA, IT | JIX |
| Jun 19, 2008 | K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY SENTINEL CH. SpA, IT | JFY |
| Aug 2, 2007 | K070987 | SENTINEL LITHIUM ASSAY SENTINEL CH. SpA, IT | NDW |
| May 23, 2007 | K070971 | MODIFICATION TO SENTINEL CLIN CHEM CAL Sentinel Ch. Srl, IT | JIX |
| Jan 26, 2006 | K051447 | SENTINEL PANCREATIC AMYLASE Sentinel Ch. Srl, IT | JFJ |
| Nov 25, 2005 | K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY Sentinel Ch. Srl, IT | JIF |
| Nov 17, 2005 | K051111 | SENTINEL UIBC LIQUID Sentinel Ch. Srl, IT | JQF |
| Oct 25, 2005 | K051452 | SENTINEL CLIN CHEM CAL Sentinel Ch. Srl, IT | JIX |
| Oct 21, 2005 | K051456 | SENTINEL CERULOPLASMIN Sentinel Ch. Srl, IT | JFR |
| Aug 25, 2005 | K051115 | SENTINEL IRON LIQUID Sentinel Ch. Srl, IT | JIY |
| Aug 8, 2005 | K050836 | CRP DIAGNOSTIC ASSAY Sentinel Ch. Srl, IT | DCK |
| Jul 25, 2005 | K051457 | SENTINEL PLASMAPROTEINS CAL 3X Sentinel Ch. Srl, IT | JIX |
| Jun 20, 2005 | K051444 | SENTINEL CHOLINESTERASE LIQUID Sentinel Ch. Srl, IT | DIH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Sentinel CH SpA Alinity c Iron Reagent, Reference Number 08P3920 Open, Classified |
JIY | None listed |
| Nov 17, 2023 | Sentinel CH SpA IRON assay, Reference Numbers 6K95-41 and 6K95-30 Open, Classified |
JIY | None listed |
| Jul 29, 2021 | Sentinel CH SpA 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], o Terminated |
JIS | None listed |
| Apr 30, 2021 | Sentinel CH SpA ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE)
REF 1667001 Open, Classified |
JJX | None listed |
| Jun 28, 2019 | Sentinel CH SpA Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer
List Number: 08P5320 Terminated |
NDW | K070987 |
| Jun 28, 2019 | Sentinel CH SpA MULTIGENT Lithium-intended for the quantitation of lithium in
serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer
List Number: 8L25-30 Terminated |
NDW | K070987 |
| Jun 27, 2017 | Sentinel CH SPA MULTIGENT 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
Terminated |
JFY | K073634 |
| Oct 26, 2015 | Sentinel CH SpA Sentinel 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. Terminated |
JIF | K051114 |