Karen Anderson

FDA Filings

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

Karen Anderson holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9681477
FEI Number3002807439
NameKaren Anderson
Owner & OperatorLake Region Medical
Contact Address340 Lake Hazeltine Drive --
Chaska MN 55318 US
Official Correspondent
  • Karen - Anderson
  • x-952-6418509-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address340 Lake Hazeltine Dr
CHASKA, MN 55318 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number8023024
FEI Number6387
NameKaren Anderson
Owner & OperatorSEBIA
Contact AddressPARC TECHNOLOGIQUE LEONARD DE 27 rue Leonard de VINCI
Lisses-Evry FR-NOTA 91008 FR
Official Correspondent
  • Arnaud - Collin
  • 33-169-898331-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400-1705 Corporate Drive
Norcross, GA 30093 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2019-11-04
Karen Anderson [SEBIA]
HYDRASHIFT 2 /4 daratumumab2019-05-29
Karen Anderson [SEBIA]
CAPI 3 HEMOGLOBIN TERA, CAPI 3 HEMOGLOBIN OCTA2018-12-17
Karen Anderson [SEBIA]
Minicap HbA1c using the Minicap Flex Piercing2018-09-16
Karen Anderson [SEBIA]
Minicap HbA1c using the Minicap Flex Piercing2018-09-16
Karen Anderson [SEBIA]
Minicap HbA1c using the Minicap Flex Piercing2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING2018-09-16
Karen Anderson [SEBIA]
CAPILLARYS HB A1C USING CAPILLARYS 2 FLEX PIERCING2018-09-15
Karen Anderson [SEBIA]
HYDRASHIFT 2/4 daratumumab and daratumumab control2018-08-15
Karen Anderson [SEBIA]
HYDRASHIFT 2/4 daratumumab and daratumumab control2018-08-15
Karen Anderson [SEBIA]
CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA2017-11-03
Karen Anderson [SEBIA]
CAPi3 HbA1c2017-02-21
Karen Anderson [SEBIA]
CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA2017-02-21
Karen Anderson [SEBIA]
CAPi3 HbA1c2017-02-21
Karen Anderson [SEBIA]
CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA2017-02-21
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA2016-12-29
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [SEBIA]
Minicap Immunotyping using the Minicap Flex Piercing instrument2016-11-09
Karen Anderson [Lake Region Medical]
Predicate III2014-10-30
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
Gelscan2013-11-19
Karen Anderson [SEBIA]
CAPILLARYS NEONAT HB2013-11-19
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Immunotyping2013-11-18
Karen Anderson [SEBIA]
Minicap Hemoglobin2013-11-18
Karen Anderson [SEBIA]
Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing2012-12-18
Karen Anderson [SEBIA]
Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing2012-12-18
Karen Anderson [SEBIA]
Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing2012-12-18
Karen Anderson [SEBIA]
Capillarys CDT -Capillarys 2 Flex Piercing2012-07-24
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
IT/IF Control2012-06-08
Karen Anderson [SEBIA]
Capillarys 2 flex piercing- Capillarys Hemoglobin2012-06-07
Karen Anderson [SEBIA]
Capillarys 2- Capillarys Hemoglobin2012-06-07
Karen Anderson [SEBIA]
Capillarys 2 flex piercing- Protein 62012-06-07
Karen Anderson [Lake Region Medical]
K9351982009-02-05
Karen Anderson [Lake Region Medical]
K0801442008-11-03
Karen Anderson [SEBIA]
Hydragel Immunofixation2008-07-23
Karen Anderson [SEBIA]
Iso-Pal control2008-07-23
Karen Anderson [SEBIA]
Capillarys Urine2008-07-23
Karen Anderson [SEBIA]
Hydragel 18 A1AT ISOFOCUSING2008-07-23
Karen Anderson [SEBIA]
Hydragel 18 A1AT ISOFOCUSING2008-07-23
Karen Anderson [SEBIA]
Hb AFSC control2008-07-23
Karen Anderson [SEBIA]
Capillarys Hemoglobin(e)2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Capillarys Immunotyping2008-07-23
Karen Anderson [SEBIA]
Normal Control Serum2008-07-23
Karen Anderson [SEBIA]
Hypergamma Control Serum2008-07-23
Karen Anderson [SEBIA]
Hydragel CSF Isofocusing2008-07-23
Karen Anderson [SEBIA]
Hydragel Bence Jones Kit2008-05-13
Karen Anderson [SEBIA]
HYDRAGEL ISO-CK2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ACID(E) HEMOGLOBIN(E)2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL CSF2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ISO-LDH2007-12-18
Karen Anderson [SEBIA]
HYDRAGEL ISO-PAL2007-12-18
Karen Anderson [Lake Region Medical]
K9703762007-12-05
Karen Anderson [Lake Region Medical]
K9351702007-12-05
Karen Anderson [Lake Region Medical]
Torque Device2007-12-05
Karen Anderson [Lake Region Medical]
K8508292007-12-05
Karen Anderson [Lake Region Medical]
K7709772007-12-05
Karen Anderson [SEBIA]
HYDRAGEL LIPOPROTEIN(E)1998-10-26
Karen Anderson [SEBIA]
HYDRAGEL LDL/HDL CHOL Direct1997-06-18
Karen Anderson [SEBIA]
HYDRASYS1996-04-01
Karen Anderson [SEBIA]
HYDRAGEL HR1995-05-24

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Related Finance Registrations
NCAGE Code3EW54KAREN ANDERSON!DBA JIM & KAREN SALES & SERVICE
CAGE Code3EW54KAREN ANDERSON JIM & KAREN SALES & SERVICE
DUNS160232518KAREN ANDERSON
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092985344Yantian,China (Mainland) -> Los Angeles, CaliforniaPICTURE AND PAINTINGS1 PCS
2020091047569Yantian,China (Mainland) -> Los Angeles, CaliforniaCOSTUME JEWELRY1 PCS
2020090966525Yantian,China (Mainland) -> Los Angeles, CaliforniaCOSTUME JEWELRY1 PCS
2020090266277Yantian,China (Mainland) -> Los Angeles, CaliforniaCOSTUME JEWELRY1 PCS
2020082265675Yantian,China (Mainland) -> Los Angeles, CaliforniaDIY DECORATION ACCESSORIES1 PCS
2020082271318Yantian,China (Mainland) -> Los Angeles, CaliforniaDIY DECORATION ACCESSORIES1 PCS
2020081588651Yantian,China (Mainland) -> Long Beach, CaliforniaHOME DECOR ATRICLE1 PCS
20200811108618Yantian,China (Mainland) -> Los Angeles, CaliforniaPLUSH TOYS1 PCS
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