Genolution Inc

FDA Filings

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

FDA Registration(s)
Registration Number3013096769
FEI Number3013096769
NameGENOLUTION INC.
Owner & OperatorGenolution Inc.
Contact AddressRm 506 Bldg A, 11 Beobwon-ro 11-gil, Songpa-gu
Seoul KR-11 Seoul Teugbyeolsi 05836 KR
Official Correspondent
  • Duek Soo Na
  • 82-2-4498670-0151
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressRm 506, Bldg.A, 11 Beobwon-ro 11-gil, Songpa-gu
Seoul Seoul Teugbyeolsi, 05836 KR
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
GENOLUTION. INC.
NX Genomic DNA Kit B NGD042 2023-11-16
GENOLUTION. INC.
NX Genomic DNA Kit B NGD322 2023-11-16
GENOLUTION. INC.
NX Genomic DNA Kit B NGD962 2023-11-16
GENOLUTION. INC.
NX Genomic DNA Kit A NGD041 2023-11-16
GENOLUTION. INC.
NX Genomic DNA Kit A NGD321 2023-11-16
GENOLUTION. INC.
NX Universal DNA Kit C NUE043 2023-11-16
GENOLUTION. INC.
NX Universal DNA Kit C NUE323 2023-11-16
GENOLUTION. INC.
NX Universal DNA Kit C NUE963 2023-11-16
GENOLUTION. INC.
NX Universal DNA Kit B NUE042 2023-11-16
GENOLUTION. INC.
NX Universal DNA Kit B NUE322 2023-11-16
GENOLUTION. INC.
NX Universal DNA Kit B NUE962 2023-11-16
GENOLUTION. INC.
NX Universal NA Kit A NUE041 2023-11-16
GENOLUTION. INC.
NX Universal NA Kit A NUE321 2023-11-16
GENOLUTION. INC.
NX Universal NA Kit A NUE961 2023-11-16
GENOLUTION. INC.
NX-Duo Genomic DNA Kit B DGD241 2023-11-15
GENOLUTION. INC.
NX-Duo Genomic DNA Kit B DGD482 2023-11-15
GENOLUTION. INC.
NX-Duo Genomic DNA Kit B DGD962 2023-11-15
GENOLUTION. INC.
NX-Duo Genomic DNA Kit A DGD241 2023-11-15
GENOLUTION. INC.
NX-Duo Genomic DNA Kit A DGD481 2023-11-15
GENOLUTION. INC.
NX-Duo Genomic DNA Kit A DGD961 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit C DUE243 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit C DUE963 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit B DUE242 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit B DUE482 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit B DUE962 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit A DUE241 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit A DUE481 2023-11-15
GENOLUTION. INC.
NX-Duo Universal DNA Kit A DUE961 2023-11-15
GENOLUTION. INC.
NX-Duo cfDNA Kit A DCF244 2023-11-15
GENOLUTION. INC.
NX-Duo cfDNA Kit A DCF242 2023-11-15
GENOLUTION. INC.
NX-Duo Stool NA Kit A DSN241 2023-11-09
GENOLUTION. INC.
NX-Duo Stool NA Kit A DSN481 2023-11-09
GENOLUTION. INC.
NX-Duo Stool NA Kit A DSN961 2023-11-09
GENOLUTION. INC.
NX Stool NA Kit A CSN241 2023-11-09
GENOLUTION. INC.
NX Stool NA Kit A CSN231 2023-11-09
GENOLUTION. INC.
NX Stool NA Kit A CSN291 2023-11-09
GENOLUTION. INC.
Viral NA Kit VN001 2023-11-02
GENOLUTION. INC.
NX Genomic DNA Kit A NGD961 2023-11-02
GENOLUTION. INC.
NX-Duo Viral NA Kit A DVN961 2023-11-02
GENOLUTION. INC.
Nextractor NX-Duo 2023-11-02
GENOLUTION. INC.
Nextractor NX-48N 2023-11-02
GENOLUTION INC.
Nx-Jr Plant DNA Kit PD131, PD1322016-10-05
GENOLUTION INC.
Nx-Jr Genomic DNA Kit GD131, GD1322016-10-05
GENOLUTION INC.
Nx-Jr Food DNA Kit FD1312016-10-05
GENOLUTION INC.
Nextractor NX-Jr2016-10-05
GENOLUTION INC.
Nextractor NX-48S2016-10-05
GENOLUTION INC.
Nextractor NX-482016-10-05
GENOLUTION INC.
NX-Jr Viral RNA Kit VR1322016-10-05
GENOLUTION INC.
NX-Jr Viral NA Kit VN131, VN132, VN1332016-10-05
GENOLUTION INC.
NX-Jr Viral DNA Kit VD1312016-10-05
GENOLUTION INC.
NX-Jr Urine/Swab DNA Kit US131, US1322016-10-05
GENOLUTION INC.
NX-Jr Tissue DNA Kit TD1312016-10-05
GENOLUTION INC.
NX-Jr Stool RNA Kit SR1312016-10-05
GENOLUTION INC.
NX-Jr Stool DNA Kit SD1312016-10-05
GENOLUTION INC.
NX-Jr FFPE DNA Kit FF1312016-10-05
GENOLUTION INC.
NX-Jr Cell RNA Kit CR1312016-10-05
GENOLUTION INC.
NX-Jr Cell DNA Kit CD1312016-10-05
GENOLUTION INC.
NX-Jr Bacterial DNA Kit BD133, BD1362016-10-05
GENOLUTION INC.
NX-48S Viral RNA Kit VR142, VR152, VR1622016-10-05
GENOLUTION INC.
NX-48S Viral NA Kit VN141, VN151, VN161, VN142, VN152, VN162, VN143, VN153, VN1632016-10-05
GENOLUTION INC.
NX-48S Viral DNA Kit VD141, VD151, VD1612016-10-05
GENOLUTION INC.
NX-48S Urine/Swab DNA Kit US141, US151, US161, US142, US152, US1622016-10-05
GENOLUTION INC.
NX-48S Tissue DNA Kit TD141, TD151, TD1612016-10-05
GENOLUTION INC.
NX-48S Stool RNA Kit SR141, SR151, SR1612016-10-05
GENOLUTION INC.
NX-48S Stool DNA Kit SD141, SD151, SD1612016-10-05
GENOLUTION INC.
NX-48S Plant DNA Kit PD141, PD151, PD161, PD142, PD152, PD1622016-10-05
GENOLUTION INC.
NX-48S Genomic DNA Kit GD141, GD151, GD161, GD142, GD152, GD1622016-10-05
GENOLUTION INC.
NX-48S Food DNA Kit FD141, FD151, FD1612016-10-05
GENOLUTION INC.
NX-48S FFPE DNA Kit FF141, FF151, FF1612016-10-05
GENOLUTION INC.
NX-48S Cell RNA Kit CR151, CR151, CR1612016-10-05
GENOLUTION INC.
NX-48S Cell DNA Kit CD141, CD151, CD1612016-10-05
GENOLUTION INC.
NX-48S Bacterial DNA Kit BD143, BD153, BD163, BD146, BD156, BD1662016-10-05
GENOLUTION INC.
NX-48 Whole Blood Kit WB101, WB111, WB1212016-10-05
GENOLUTION INC.
NX-48 Viral RNA Kit VR102, VR112, VR1222016-10-05
GENOLUTION INC.
NX-48 Viral NA Kit VN101, VN111, VN121, VN102, VN112, VN122, VN103, VN113, VN1232016-10-05
GENOLUTION INC.
NX-48 Viral DNA Kit VD101, VD111, VD1212016-10-05
GENOLUTION INC.
NX-48 Urine/Swab DNA Kit US 101, US111, US121, US102, US112, US1222016-10-05
GENOLUTION INC.
NX-48 Tissue DNA Kit TD101, TD111, TD1212016-10-05
GENOLUTION INC.
NX-48 Stool RNA Kit SR101, SR111, SR1212016-10-05
GENOLUTION INC.
NX-48 Stool DNA KIt SD101, SD111, SD1212016-10-05
GENOLUTION INC.
NX-48 Plant DNA Kit PD101, PD111, PD121, PD102, PD112, PD1222016-10-05
GENOLUTION INC.
NX-48 FFPE DNA Kit FF101, FF111, FF1212016-10-05
GENOLUTION INC.
NX-48 Cell RNA Kit CR101, CR111, CR1212016-10-05
GENOLUTION INC.
NX-48 Cell DNA Kit CD101, CD111, CD1212016-10-05
GENOLUTION INC.
NX-48 Bacterial DNA Kit BD101, BD111, BD121, BD103, BD113, BD123, BD104, BD114, BD124, BD106, BD116, BD1262016-10-05

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