Sentinel Ch S P A

FDA Filings

This page includes the latest FDA filings for Sentinel Ch S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9681753
FEI Number3000303338
NameMichael Smith
Owner & OperatorSENTINEL CH. SPA
Contact AddressVIA ROBERT KOCH, 2 --
MILANO IT-NOTA 20152 IT
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address180 Cabot St
BEVERLY, MA 01915 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
SENTINEL CH. SPA
 Lp(a) Control Set 11522012024-03-25
SENTINEL CH. SPA
 Lp(a) Cal Set 11522D2024-03-25
SENTINEL CH. SPA
 Lp(a) Ultra 11504D2024-03-25
SENTINEL CH. SPA
 Ammonia Ultra 176602023-11-30
SENTINEL CH. SPA
 Lipase Color Liquid 17401B2023-07-06
SENTINEL CH. SPA
 CRP Ultra (MP) 1156462022-06-10
SENTINEL CH. SPA
 Clin Chem Cal 165502020-12-21
SENTINEL CH. SPA
 Clin Chem Control 2 162502020-03-26
SENTINEL CH. SPA
 Clin Chem Control 1 161502020-03-26
SENTINEL CH. SPA
 Albumin BCP (6x50 mL) C228562020-03-03
SENTINEL CH. SPA
 Albumin BCP (6x20 mL) C228552020-03-03
SENTINEL CH. SPA
 Immuno Control Set 11211A2020-02-25
Michael Smith [SENTINEL CH. SPA]
Albumin BCP (6x50 mL)2020-02-21
Michael Smith [SENTINEL CH. SPA]
Albumin BCP (6x20 mL)2020-02-21
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario Reagent Kit2019-12-23
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario Wide Range Calibrator Kit2019-12-23
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario High Sensitivity Calibrator Kit2019-12-23
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit2019-12-23
Sentinel CH. SpA
Albumin BCP2019-12-19
Sentinel CH, Spa
CRP Vario2019-11-08
SENTINEL CH. SPA
 Lipase NG OC Reagent Kit 04Y85-202019-04-24
SENTINEL CH. SPA
 Lipase NG OC CTRL 2 04Y85-112019-04-24
SENTINEL CH. SPA
 Lipase NG OC CTRL 1 04Y85-102019-04-24
SENTINEL CH. SPA
 Lipase NG OC Cal 04Y85-012019-04-24
Michael Smith [SENTINEL CH. SPA]
CRP Vario2018-10-31
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario Reagent Kit2018-10-31
Michael Smith [SENTINEL CH. SPA]
Immuno Control Set2018-10-31
Michael Smith [SENTINEL CH. SPA]
Clin Chem Control 22018-10-31
Michael Smith [SENTINEL CH. SPA]
Clin Chem Control 12018-10-31
SENTINEL CH. SpA
CRP Vario2018-09-27
Michael Smith [SENTINEL CH. SPA]
Lipase NG OC Cal2018-09-25
Michael Smith [SENTINEL CH. SPA]
Alinity c UIBC Calibrator Kit2018-09-25
Michael Smith [SENTINEL CH. SPA]
Alinity c UIBC Reagent Kit2018-08-22
Michael Smith [SENTINEL CH. SPA]
Alinity c Iron Reagent Kit2018-08-22
Michael Smith [SENTINEL CH. SPA]
Ceruloplasmin2018-08-22
Michael Smith [SENTINEL CH. SPA]
Alinity c Ceruloplasmin Reagent Kit2018-08-22
Michael Smith [SENTINEL CH. SPA]
Plasmaproteins Cal 3x2018-07-13
Michael Smith [SENTINEL CH. SPA]
Alinity c Plasmaproteins Cal 3x Kit2018-07-13
Michael Smith [SENTINEL CH. SPA]
Alinity c Clinical Chemistry Calibrator Kit2018-07-13
Michael Smith [SENTINEL CH. SPA]
Lipase NG OC CTRL 22018-07-04
Michael Smith [SENTINEL CH. SPA]
Lipase NG OC CTRL 12018-07-04
Michael Smith [SENTINEL CH. SPA]
Alinity c Ammonia Controls2018-07-04
Michael Smith [SENTINEL CH. SPA]
Alinity c Reagent Cartridge Black2018-05-17
Michael Smith [SENTINEL CH. SPA]
Lipase NG Cal2016-07-20
Michael Smith [SENTINEL CH. SPA]
ACE Control Set2016-03-22
Michael Smith [SENTINEL CH. SPA]
ACE Calibrator2016-03-21
Michael Smith [SENTINEL CH. SPA]
ACE Liquid2016-03-21
Michael Smith [SENTINEL CH. SPA]
Cholinesterase2014-12-01
Michael Smith [SENTINEL CH. SPA]
Cholinesterase2014-12-01
SENTINEL CH. SpA
ACE CALIBRATOR2014-07-28
Michael Smith [SENTINEL CH. SPA]
Sentinel Lipase Liquid2014-01-30
Michael Smith [SENTINEL CH. SPA]
Lipase NG2014-01-30
Michael Smith [SENTINEL CH. SPA]
Lipase NG OC Reagent Kit2014-01-30
Michael Smith [SENTINEL CH. SPA]
Clin Chem Cal2014-01-30
Michael Smith [SENTINEL CH. SPA]
CKMB UDR2011-08-24
SENTINEL CH. SpA
CKMB UDR ASSAY2011-08-19
Michael Smith [SENTINEL CH. SPA]
Kappa Light Chains2009-09-17
Michael Smith [SENTINEL CH. SPA]
Lambda Light Chains2009-09-17
SENTINEL CH. SpA
KAPPA LIGHT CHAINS2009-09-03
SENTINEL CH. SpA
LAMBDA LIGHT CHAINS2009-06-22
Michael Smith [SENTINEL CH. SPA]
Plasmaproteins Cal 3x2009-04-16
Michael Smith [SENTINEL CH. SPA]
Alpha 1-Acid Glycoprotein2009-04-16
Michael Smith [SENTINEL CH. SPA]
Creatinine (Enzymatic)2008-07-29
Michael Smith [SENTINEL CH. SPA]
Alinity c Creatinine (Enzymatic) Reagent Kit2008-07-29
SENTINEL CH. SpA
SENTINEL PLASMAPROTEINS CAL 3X2008-06-25
SENTINEL CH. SpA
MULTIGENT CREATININE (ENZYMATIC) ASSAY2008-06-19
Michael Smith [SENTINEL CH. SPA]
Multigent Lithium Assay2007-11-07
Michael Smith [SENTINEL CH. SPA]
Alinity c Lithium Reagent Kit2007-11-07
SENTINEL CH SPA
SENTINEL LITHIUM ASSAY2007-08-02
Michael Smith [SENTINEL CH. SPA]
PANCREATIC AMYLASE2006-03-28
Michael Smith [SENTINEL CH. SPA]
Alinity c Ammonia Ultra Reagent Kit2006-03-16
Michael Smith [SENTINEL CH. SPA]
AMMONIA ULTRA2006-03-16
Michael Smith [SENTINEL CH. SPA]
AMMONIA CONTROLS2006-03-16
Michael Smith [SENTINEL CH. SPA]
Alinity c Ammonia Ultra Reagent Kit2006-03-16
Michael Smith [SENTINEL CH. SPA]
AMMONIA ULTRA2006-03-16
Michael Smith [SENTINEL CH. SPA]
AMMONIA CONTROLS2006-03-16
Michael Smith [SENTINEL CH. SPA]
UIBC2006-03-16
Michael Smith [SENTINEL CH. SPA]
UIBC LIQUID2006-03-16
Michael Smith [SENTINEL CH. SPA]
PLASMAPROTEINS CAL 3X2005-11-17
Michael Smith [SENTINEL CH. SPA]
CERULOPLASMIN2005-11-17
Michael Smith [SENTINEL CH. SPA]
Sentinel Iron Liquid2005-11-17
Michael Smith [SENTINEL CH. SPA]
Iron2005-11-17
Michael Smith [SENTINEL CH. SPA]
IRON LIQUID2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP VARIO2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CONTROL HS2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR WR2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR SET2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR HS2005-11-17
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario HS Control Kit2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP VARIO2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CONTROL HS2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR WR2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR SET2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR HS2005-11-17
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario HS Control Kit2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP VARIO2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CONTROL HS2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR WR2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR SET2005-11-17
Michael Smith [SENTINEL CH. SPA]
CRP CALIBRATOR HS2005-11-17
Michael Smith [SENTINEL CH. SPA]
Alinity c CRP Vario HS Control Kit2005-11-17

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