Michael Smith

FDA Filings

This page includes the latest FDA filings for Michael Smith. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008937712
FEI Number3008937712
NameMichael Smith
Owner & OperatorSeegene Inc.
Contact AddressTaewon Building 91, Ogeum-Ro
Songpa-gu KR-11 Seoul Teugbyeolsi 05548 KR
Official Correspondent
  • Jung-Woo Eo
  • 82-2-22405559-x
US Agent
Importing Logistics Registration
ImporterSeegene Technologies
Address325 North Wiget Lane Suite 140
Walnut Creek, CA 94598 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address180 Cabot St
Beverly, MA 01915 US
Establishment TypeManufacture Medical Device

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
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
Michael Smith [Seegene Inc.]
Seegene STARlet2019-05-28
Michael Smith [Seegene Inc.]
Seegene NIMBUS2019-05-28
Michael Smith [Seegene Inc.]
STARMag 96x4 Universal Plus Cartridge Kit2019-05-28
Michael Smith [Seegene Inc.]
STARMag 96x4 Universal Cartridge Kit2019-05-28
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
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
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
Michael Smith [SENTINEL CH. SPA]
Kappa Light Chains2009-09-17
Michael Smith [SENTINEL CH. SPA]
Lambda Light Chains2009-09-17
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
Michael Smith [SENTINEL CH. SPA]
Multigent Lithium Assay2007-11-07
Michael Smith [SENTINEL CH. SPA]
Alinity c Lithium Reagent Kit2007-11-07
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

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeKCDY8MICHAEL SMITH
NCAGE Code1W7A8MICHAEL SMITH!DBA AAA PATTERNS & MARKING SERVICES
CAGE Code1W7A8MICHAEL SMITH AAA PATTERNS & MARKING SERVICES
CAGE CodeKCDY8MICHAEL SMITH
DUNS034049218MICHAEL SMITH
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020070775776Yantian,China (Mainland) -> Los Angeles, CaliforniaHANDTOOL SUPPLIES1 PCS
202006308593Bremerhaven,Federal Republic of Germany -> Baltimore, MarylandVAN VIN: 1C6RR7HT5GS1466771 VPK
2020061544121Yantian,China (Mainland) -> Oakland, CaliforniaA HUMMINGBIRD LAMP1 PCS
202006037278Southhampton,United Kingdom -> Galveston, TexasHOUSEHOLD GOODS1 BOX
2020060331357Yantian,China (Mainland) -> Oakland, CaliforniaBELT FOLDING SHOVELS1 PCS
2020060170404Yantian,China (Mainland) -> Oakland, CaliforniaCONVERTER1 PCS
2020060155991Yantian,China (Mainland) -> Oakland, CaliforniaHIKING SHOES1 PCS
2020052550634Yantian,China (Mainland) -> Oakland, CaliforniaBUBBLEWORLD BUBBLEWORLD1 PCS
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