Medical Device Manufacturer · IT , Milano

SENTINEL CH. SpA

12 submissions · 12 cleared · Since 2007
12
Total
12
Cleared
0
Denied

SENTINEL CH. SpA — FDA 510(k) Submissions

SENTINEL CH. SpA has submitted 12 FDA 510(k) premarket notifications since 2007, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cardiac C-reactive Protein, Antigen, Antiserum, And Control, C-reactive Protein, Antigen, Antiserum, And Control, Bromcresol Purple Dye-binding, Albumin, Lipoprotein, Low-density, Antigen, Antiserum, Control, Assay, Porphyrin, Spectrophotometry, Lithium . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Cystatin C
K242585 · NDY Test, Cystatin C · Chemistry
May 2025 259d
Lp(a) Ultra
K211058 · DFC Lipoprotein, Low-density,... · Chemistry
Dec 2022 622d
Albumin BCP
K193001 · CJW Bromcresol Purple... · Chemistry
Dec 2019 52d
CRP Vario
K192118 · DCK C-reactive Protein,... · Immunology
Nov 2019 94d
CRP Vario
K173833 · NQD Cardiac C-reactive... · Chemistry
Sep 2018 283d
ACE CALIBRATOR
K141728 · JIT Calibrator, Secondary · Chemistry
Jul 2014 32d
CKMB UDR ASSAY
K102706 · JHS Differential Rate Kinetic... · Chemistry
Aug 2011 333d
KAPPA LIGHT CHAINS
K083602 · DFH Kappa, Antigen,... · Immunology
Sep 2009 272d
LAMBDA LIGHT CHAINS
K083601 · DEH Lambda, Antigen,... · Immunology
Jun 2009 199d
SENTINEL PLASMAPROTEINS CAL 3X
K081533 · JIX Calibrator, Multi-analyte... · Chemistry
Jun 2008 23d
MULTIGENT CREATININE (ENZYMATIC) ASSAY
K073634 · JFY Enzymatic Method, Creatinine · Chemistry
Jun 2008 176d
SENTINEL LITHIUM ASSAY
K070987 · NDW Assay, Porphyrin,... · Toxicology
Aug 2007 118d
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