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 Number: 9681753
• FEI Number: 3000303338
• Name: Michael Smith
• Owner & Operator: SENTINEL CH. SPA
• Contact Address: VIA ROBERT KOCH, 2 --; MILANO IT-NOTA 20152 IT
• US Agent:
  • Michael Smith
  • MDC Associates, Inc
  • 978 9273808
  • 866 5402448
  • regulatory@mdcassoc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 180 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	Device	Date
GUDID 08058056685445 SENTINEL CH. SPA	Alinity c ACE Assay File 06U86-1A	2025-03-18
GUDID 08058056685438 SENTINEL CH. SPA	ARCHITECT c ACE Assay File 6U82-1A	2025-03-18
GUDID 08058056685339 SENTINEL CH. SPA	ACE Reagent 06U8625	2025-02-04
GUDID 08058056685322 SENTINEL CH. SPA	ACE Control 06U8610	2025-02-04
GUDID 08058056685315 SENTINEL CH. SPA	ACE Calibrator 06U8601	2025-02-04
GUDID 08058056685308 SENTINEL CH. SPA	ACE Reagent 06U8225	2025-02-04
GUDID 08058056685292 SENTINEL CH. SPA	ACE Control 06U8210	2025-02-04
GUDID 08058056685285 SENTINEL CH. SPA	ACE Calibrator 06U8201	2025-02-04
GUDID 08058056681744 SENTINEL CH. SPA	Lp(a) Control Set 1152201	2024-03-25
GUDID 08058056680228 SENTINEL CH. SPA	Lp(a) Cal Set 11522D	2024-03-25
GUDID 08058056680211 SENTINEL CH. SPA	Lp(a) Ultra 11504D	2024-03-25
GUDID 08058056680181 SENTINEL CH. SPA	Ammonia Ultra 17660	2023-11-30
GUDID 08058056680617 SENTINEL CH. SPA	Lipase Color Liquid 17401B	2023-07-06
GUDID 08058056681911 SENTINEL CH. SPA	CRP Ultra (MP) 115646	2022-06-10
GUDID 08058056680136 SENTINEL CH. SPA	Clin Chem Cal 16550	2020-12-21
GUDID 08058056680105 SENTINEL CH. SPA	Clin Chem Control 2 16250	2020-03-26
GUDID 08058056680099 SENTINEL CH. SPA	Clin Chem Control 1 16150	2020-03-26
GUDID 08058056681980 SENTINEL CH. SPA	Albumin BCP (6x50 mL) C22856	2020-03-03
GUDID 08058056681973 SENTINEL CH. SPA	Albumin BCP (6x20 mL) C22855	2020-03-03
GUDID 08058056680204 SENTINEL CH. SPA	Immuno Control Set 11211A	2020-02-25
PMN K193001 | CJW Michael Smith [SENTINEL CH. SPA]	Albumin BCP (6x50 mL)	2020-02-21
PMN K193001 | CJW Michael Smith [SENTINEL CH. SPA]	Albumin BCP (6x20 mL)	2020-02-21
PMN K192118 | DCK Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario Reagent Kit	2019-12-23
JIS Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario Wide Range Calibrator Kit	2019-12-23
JIS Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario High Sensitivity Calibrator Kit	2019-12-23
JIS Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit	2019-12-23
PMN K193001 Sentinel CH. SpA	Albumin BCP	2019-12-19
PMN K192118 Sentinel CH, Spa	CRP Vario	2019-11-08
GUDID 08058056682321 SENTINEL CH. SPA	Lipase NG OC Reagent Kit 04Y85-20	2019-04-24
GUDID 08058056682314 SENTINEL CH. SPA	Lipase NG OC CTRL 2 04Y85-11	2019-04-24
GUDID 08058056682307 SENTINEL CH. SPA	Lipase NG OC CTRL 1 04Y85-10	2019-04-24
GUDID 08058056682291 SENTINEL CH. SPA	Lipase NG OC Cal 04Y85-01	2019-04-24
PMN K173833 | NQD Michael Smith [SENTINEL CH. SPA]	CRP Vario	2018-10-31
PMN K173833 | NQD Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario Reagent Kit	2018-10-31
JJY Michael Smith [SENTINEL CH. SPA]	Immuno Control Set	2018-10-31
JJY Michael Smith [SENTINEL CH. SPA]	Clin Chem Control 2	2018-10-31
JJY Michael Smith [SENTINEL CH. SPA]	Clin Chem Control 1	2018-10-31
PMN K173833 SENTINEL CH. SpA	CRP Vario	2018-09-27
JIT Michael Smith [SENTINEL CH. SPA]	Lipase NG OC Cal	2018-09-25
JIT Michael Smith [SENTINEL CH. SPA]	Alinity c UIBC Calibrator Kit	2018-09-25
JQF Michael Smith [SENTINEL CH. SPA]	Alinity c UIBC Reagent Kit	2018-08-22
JIY Michael Smith [SENTINEL CH. SPA]	Alinity c Iron Reagent Kit	2018-08-22
JFR Michael Smith [SENTINEL CH. SPA]	Ceruloplasmin	2018-08-22
JFR Michael Smith [SENTINEL CH. SPA]	Alinity c Ceruloplasmin Reagent Kit	2018-08-22
JIX Michael Smith [SENTINEL CH. SPA]	Plasmaproteins Cal 3x	2018-07-13
JIX Michael Smith [SENTINEL CH. SPA]	Alinity c Plasmaproteins Cal 3x Kit	2018-07-13
JIX Michael Smith [SENTINEL CH. SPA]	Alinity c Clinical Chemistry Calibrator Kit	2018-07-13
JJX Michael Smith [SENTINEL CH. SPA]	Lipase NG OC CTRL 2	2018-07-04
JJX Michael Smith [SENTINEL CH. SPA]	Lipase NG OC CTRL 1	2018-07-04
JJX Michael Smith [SENTINEL CH. SPA]	Alinity c Ammonia Controls	2018-07-04
PMN K170316 | JJE Michael Smith [SENTINEL CH. SPA]	Alinity c Reagent Cartridge Black	2018-05-17
PMN K033501 | JIX Michael Smith [SENTINEL CH. SPA]	Lipase NG Cal	2016-07-20
PMN K940272 | JJX Michael Smith [SENTINEL CH. SPA]	ACE Control Set	2016-03-22
PMN K141728 | JIT Michael Smith [SENTINEL CH. SPA]	ACE Calibrator	2016-03-21
KQN Michael Smith [SENTINEL CH. SPA]	ACE Liquid	2016-03-21
PMN K981800 | HIH Michael Smith [SENTINEL CH. SPA]	Cholinesterase	2014-12-01
PMN K981800 | DLI Michael Smith [SENTINEL CH. SPA]	Cholinesterase	2014-12-01
PMN K141728 SENTINEL CH. SpA	ACE CALIBRATOR	2014-07-28
PMN K961179 | CHI Michael Smith [SENTINEL CH. SPA]	Sentinel Lipase Liquid	2014-01-30
PMN K961179 | CHI Michael Smith [SENTINEL CH. SPA]	Lipase NG	2014-01-30
PMN K961179 | CHI Michael Smith [SENTINEL CH. SPA]	Lipase NG OC Reagent Kit	2014-01-30
PMN K070971 | JIX Michael Smith [SENTINEL CH. SPA]	Clin Chem Cal	2014-01-30
PMN K102706 | JHS Michael Smith [SENTINEL CH. SPA]	CKMB UDR	2011-08-24
PMN K102706 SENTINEL CH. SpA	CKMB UDR ASSAY	2011-08-19
PMN K083602 | DFH Michael Smith [SENTINEL CH. SPA]	Kappa Light Chains	2009-09-17
PMN K083601 | DEH Michael Smith [SENTINEL CH. SPA]	Lambda Light Chains	2009-09-17
PMN K083602 SENTINEL CH. SpA	KAPPA LIGHT CHAINS	2009-09-03
PMN K083601 SENTINEL CH. SpA	LAMBDA LIGHT CHAINS	2009-06-22
PMN K081533 | JIX Michael Smith [SENTINEL CH. SPA]	Plasmaproteins Cal 3x	2009-04-16
LKL Michael Smith [SENTINEL CH. SPA]	Alpha 1-Acid Glycoprotein	2009-04-16
PMN K073634 | JFY Michael Smith [SENTINEL CH. SPA]	Creatinine (Enzymatic)	2008-07-29
PMN K073634 | JFY Michael Smith [SENTINEL CH. SPA]	Alinity c Creatinine (Enzymatic) Reagent Kit	2008-07-29
PMN K081533 SENTINEL CH. SpA	SENTINEL PLASMAPROTEINS CAL 3X	2008-06-25
PMN K073634 SENTINEL CH. SpA	MULTIGENT CREATININE (ENZYMATIC) ASSAY	2008-06-19
PMN K070987 | NDW Michael Smith [SENTINEL CH. SPA]	Multigent Lithium Assay	2007-11-07
PMN K070987 | NDW Michael Smith [SENTINEL CH. SPA]	Alinity c Lithium Reagent Kit	2007-11-07
PMN K070987 SENTINEL CH SPA	SENTINEL LITHIUM ASSAY	2007-08-02
PMN K051447 | JFJ Michael Smith [SENTINEL CH. SPA]	PANCREATIC AMYLASE	2006-03-28
PMN K051114 | JJX Michael Smith [SENTINEL CH. SPA]	Alinity c Ammonia Ultra Reagent Kit	2006-03-16
PMN K051114 | JJX Michael Smith [SENTINEL CH. SPA]	AMMONIA ULTRA	2006-03-16
PMN K051114 | JJX Michael Smith [SENTINEL CH. SPA]	AMMONIA CONTROLS	2006-03-16
PMN K051114 | JIF Michael Smith [SENTINEL CH. SPA]	Alinity c Ammonia Ultra Reagent Kit	2006-03-16
PMN K051114 | JIF Michael Smith [SENTINEL CH. SPA]	AMMONIA ULTRA	2006-03-16
PMN K051114 | JIF Michael Smith [SENTINEL CH. SPA]	AMMONIA CONTROLS	2006-03-16
PMN K051111 | JQF Michael Smith [SENTINEL CH. SPA]	UIBC	2006-03-16
PMN K051111 | JQF Michael Smith [SENTINEL CH. SPA]	UIBC LIQUID	2006-03-16
PMN K051457 | JIX Michael Smith [SENTINEL CH. SPA]	PLASMAPROTEINS CAL 3X	2005-11-17
PMN K051456 | JFR Michael Smith [SENTINEL CH. SPA]	CERULOPLASMIN	2005-11-17
PMN K051115 | JIY Michael Smith [SENTINEL CH. SPA]	Sentinel Iron Liquid	2005-11-17
PMN K051115 | JIY Michael Smith [SENTINEL CH. SPA]	Iron	2005-11-17
PMN K051115 | JIY Michael Smith [SENTINEL CH. SPA]	IRON LIQUID	2005-11-17
PMN K050836 | JJY Michael Smith [SENTINEL CH. SPA]	CRP VARIO	2005-11-17
PMN K050836 | JJY Michael Smith [SENTINEL CH. SPA]	CRP CONTROL HS	2005-11-17
PMN K050836 | JJY Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR WR	2005-11-17
PMN K050836 | JJY Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR SET	2005-11-17
PMN K050836 | JJY Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR HS	2005-11-17
PMN K050836 | JJY Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario HS Control Kit	2005-11-17
PMN K050836 | JIS Michael Smith [SENTINEL CH. SPA]	CRP VARIO	2005-11-17
PMN K050836 | JIS Michael Smith [SENTINEL CH. SPA]	CRP CONTROL HS	2005-11-17
PMN K050836 | JIS Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR WR	2005-11-17
PMN K050836 | JIS Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR SET	2005-11-17
PMN K050836 | JIS Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR HS	2005-11-17
PMN K050836 | JIS Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario HS Control Kit	2005-11-17
PMN K050836 | DCK Michael Smith [SENTINEL CH. SPA]	CRP VARIO	2005-11-17
PMN K050836 | DCK Michael Smith [SENTINEL CH. SPA]	CRP CONTROL HS	2005-11-17
PMN K050836 | DCK Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR WR	2005-11-17
PMN K050836 | DCK Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR SET	2005-11-17
PMN K050836 | DCK Michael Smith [SENTINEL CH. SPA]	CRP CALIBRATOR HS	2005-11-17
PMN K050836 | DCK Michael Smith [SENTINEL CH. SPA]	Alinity c CRP Vario HS Control Kit	2005-11-17