Nanoentek Inc

FDA Filings

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

KOREA REP OFKOREA EXCHANGE (KOSDAQ)039860DUNS 687910463
FDA Registration(s)
Registration Number3009092698
FEI Number3009092698
NameNANOENTEK INC
Owner & OperatorNanoEnTek Inc
Contact Address240 Bear Hill Road Suite 101
Waltham MA 02451 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address12F, 5, Digital-ro 26-gil Guro-gu
Seoul Seoul Teugbyeolsi, 08389 KR
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3007113174
FEI Number3007113174
NameNANOENTEK AMERICA INC
Owner & OperatorNanoEnTek Inc
Contact Address240 Bear Hill Road Suite 101
Waltham MA 02451 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address240 Bear Hill Road Suite 101
North Waltham, MA 02451 US



Registration Number3007349751
FEI Number3007349751
NameJacob Jung
Owner & OperatorNanoEnTek Inc
Contact Address240 Bear Hill Road Suite 101
Waltham MA 02451 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address240 Bear Hill Road, STE 101
Waltham, MA 02451 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Nanoentek, Inc.
Test, Residual, WBC In Leukoreduced Blood2021-10-28
NanoEnTek, Inc.
ADAM ADHK-0502021-02-23
NanoEnTek, Inc.
ADAM 2021-02-23
NanoEnTek, Inc.
C-Chip DHC-F012020-11-04
NanoEnTek, Inc.
FREND FLK-VTD2020-11-04
NanoEnTek, Inc.
FREND FLK-TSH2020-11-04
NanoEnTek, Inc.
FREND FLK-TES2020-11-04
NanoEnTek, Inc.
FREND FLK-PSA2020-11-04
NanoEnTek, Inc.
FREND FLK-FT42020-11-04
NanoEnTek, Inc.
FREND FRCOA 0202020-09-10
NanoEnTek, Inc.
FREND FIC-COALQ2020-09-10
NanoEnTek, Inc.
ADAM CD34K-0502020-09-10
NanoEnTek, Inc.
ADAM ADAM22020-09-10
NanoEnTek, Inc.
FREND FRBF 0152020-04-01
NANOENTEK INC
FREND Blocking Reagent2020-03-16
NANOENTEK INC
FRBR 0152020-03-16
Jacob Jung [NanoEnTek Inc]
FREND Blocking Reagent2020-03-16
Jacob Jung [NanoEnTek Inc]
FRBR 0152020-03-16
NanoEnTek, Inc.
FREND FRPS 0252020-02-06
NanoEnTek, Inc.
FREND FRPS 0252020-02-06
NANOENTEK INC
ADAMII2019-10-09
NANOENTEK INC
ADAMII-CD34 Kit2019-10-09
NANOENTEK INC
ADAMII CD34 System2019-10-09
Jacob Jung [NanoEnTek Inc]
ADAMII2019-10-09
Jacob Jung [NanoEnTek Inc]
ADAMII-CD34 Kit2019-10-09
Jacob Jung [NanoEnTek Inc]
ADAMII CD34 System2019-10-09
Nanoentek, Inc.
Automated Differential Cell Counter2019-08-09
NanoEnTek, Inc.
C-Chip DHC-F04202019-07-03
NanoEnTek, Inc.
C-Chip DHC-F042019-07-03
NanoEnTek, Inc.
C-Chip DHC-B04202019-07-03
NanoEnTek, Inc.
C-Chip DHC-B042019-07-03
NanoEnTek, Inc.
C-Chip DHC-N04202019-07-03
NanoEnTek, Inc.
C-Chip DHC-N042019-07-03
NANOENTEK INC
FREND Vitamin D Linearity Kit2018-09-10
NANOENTEK INC
FREND Testosterone Linearity Kit2018-09-10
NANOENTEK INC
FREND TSH Linearity Kit2018-09-10
NANOENTEK INC
FREND PSA Plus Linearity Kit2018-09-10
NANOENTEK INC
FREND Free T4 Linearity Kit2018-09-10
Jacob Jung [NanoEnTek Inc]
FREND Vitamin D Linearity Kit2018-09-10
Jacob Jung [NanoEnTek Inc]
FREND Testosterone Linearity Kit2018-09-10
Jacob Jung [NanoEnTek Inc]
FREND TSH Linearity Kit2018-09-10
Jacob Jung [NanoEnTek Inc]
FREND PSA Plus Linearity Kit2018-09-10
Jacob Jung [NanoEnTek Inc]
FREND Free T4 Linearity Kit2018-09-10
NANOENTEK INC
C-Chip DHC-N042018-09-10
NANOENTEK INC
C-Chip DHC-N04202018-09-10
NANOENTEK INC
C-Chip DHC-N012018-09-10
NANOENTEK INC
C-Chip DHC-M012018-09-10
NANOENTEK INC
C-Chip DHC-F042018-09-10
NANOENTEK INC
C-Chip DHC-F04202018-09-10
NANOENTEK INC
C-Chip DHC-F012018-09-10
NANOENTEK INC
C-Chip DHC-B042018-09-10
NANOENTEK INC
C-Chip DHC-B04202018-09-10
NANOENTEK INC
C-Chip DHC-B022018-09-10
NANOENTEK INC
C-Chip DHC-B012018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-N042018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-N04202018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-N012018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-M012018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-F042018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-F04202018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-F012018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-B042018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-B04202018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-B022018-09-10
Jacob Jung [NanoEnTek Inc]
C-Chip DHC-B012018-09-10
NANOENTEK INC
FREND AP2018-05-29
Jacob Jung [NanoEnTek Inc]
FREND AP2018-05-29
NANOENTEK INC
FREND System2017-05-25
NANOENTEK INC
FREND PSA Plus2017-05-25
Jacob Jung [NanoEnTek Inc]
FREND System2017-05-25
Jacob Jung [NanoEnTek Inc]
FREND PSA Plus2017-05-25
NANOENTEK INC
FREND Vitamin D2017-01-18
NANOENTEK INC
FREND System2017-01-18
NANOENTEK INC
FREND AP2017-01-18
Jacob Jung [NanoEnTek Inc]
FREND Vitamin D2017-01-18
Jacob Jung [NanoEnTek Inc]
FREND System2017-01-18
Jacob Jung [NanoEnTek Inc]
FREND AP2017-01-18
NANOENTEK INC
FREND Testosterone2016-10-31
NANOENTEK INC
FREND System2016-10-31
NANOENTEK INC
FREND AP2016-10-31
Jacob Jung [NanoEnTek Inc]
FREND Testosterone2016-10-31
Jacob Jung [NanoEnTek Inc]
FREND System2016-10-31
Jacob Jung [NanoEnTek Inc]
FREND AP2016-10-31
NANOENTEK INC
FREND System2016-02-17
NANOENTEK INC
FREND Free T42016-02-17
NANOENTEK INC
FREND AP2016-02-17
Jacob Jung [NanoEnTek Inc]
FREND System2016-02-17
Jacob Jung [NanoEnTek Inc]
FREND Free T42016-02-17
Jacob Jung [NanoEnTek Inc]
FREND AP2016-02-17
NANOENTEK INC
FastRapid2016-02-03
Jacob Jung [NanoEnTek Inc]
FastRapid2016-02-03
NANOENTEK INC
FREND TSH2014-03-16
NANOENTEK INC
FREND System2014-03-16
Jacob Jung [NanoEnTek Inc]
FREND TSH2014-03-16
Jacob Jung [NanoEnTek Inc]
FREND System2014-03-16
NANOENTEK INC
ADAM-rWBC2 (automatic white cell counter)2013-06-11
NANOENTEK INC
AD1K-050 (ADAM-rWBC disposable kit)2013-06-11
Jacob Jung [NanoEnTek Inc]
ADAM-rWBC2 (automatic white cell counter)2013-06-11
Jacob Jung [NanoEnTek Inc]
AD1K-050 (ADAM-rWBC disposable kit)2013-06-11
NANOENTEK INC
FRENDTM System2013-06-10
NANOENTEK INC
FRENDTM PSA Plus2013-06-10
Jacob Jung [NanoEnTek Inc]
FRENDTM System2013-06-10
Jacob Jung [NanoEnTek Inc]
FRENDTM PSA Plus2013-06-10
NANOENTEK INC
FRENDTM System2013-06-10
NANOENTEK INC
FRENDTM PSA Plus2013-06-10
Jacob Jung [NanoEnTek Inc]
FRENDTM System2013-06-10
Jacob Jung [NanoEnTek Inc]
FRENDTM PSA Plus2013-06-10
NANOENTEK INC
ADAM-rWBC2 PC Software2013-04-12
NANOENTEK INC
ADAM-rWBC PC Software2013-04-12
NANOENTEK INC
ADAM-rWBC HT PC Software2013-04-12
Jacob Jung [NanoEnTek Inc]
ADAM-rWBC2 PC Software2013-04-12
Jacob Jung [NanoEnTek Inc]
ADAM-rWBC PC Software2013-04-12
Jacob Jung [NanoEnTek Inc]
ADAM-rWBC HT PC Software2013-04-12
Nanoentek, Inc.
Automated Differential Cell Counter2012-12-05
NANOENTEK INC
ADAM-rWBC2 (automatic white cell counter)2012-08-22
NANOENTEK INC
AD1K-050 (ADAM-rWBC disposable kit)2012-08-22
Jacob Jung [NanoEnTek Inc]
ADAM-rWBC2 (automatic white cell counter)2012-08-22
Jacob Jung [NanoEnTek Inc]
AD1K-050 (ADAM-rWBC disposable kit)2012-08-22
Nanoentek, Inc.
Automated Differential Cell Counter2012-07-24
Nanoentek, Inc.
Automated Blood Grouping And Antibody Test Systems1995-11-29

Similar & Related FDA Registered Companies

Related Finance Registrations
CAGE Code55WS8NANOENTEK INC MARKETING AND SALES
CAGE Code7VZU4NANOENTEK, INC. NANOENTEK AMERICA
S.A.M. Registration7VZU4 [80693077]NANOENTEK, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020070111615Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR10 PKG
2020052520370Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR10 PKG
2020041823274Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR20 PKG
2020012113726Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR11 PKG
2020012115205Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR14 PKG
2019102815054Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR14 PKG
2019072313140Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR7 PKG
2019072217551Pusan,South Korea -> Baltimore, MarylandELECTROPORATION DEVICE MICROPORATOR16 PKG

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