Lutech Industries

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30364233833036423383Lutech Industries1N2026-01-013910 Industrial Blvd Indianapolis IN US 46254
30100237333010023733LUTECH INDUSTRIES INC.1Y2020-04-25105 Remington Blvd Suite C Ronkonkoma NY US 11779

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1535091146357129K170446LT-300 SD Digital Video ColposcopeHEX2017-05-21
3372141372680532K170446LT-300 SD Digital Video ColposcopeHEX2017-05-21
3372141259940253K160380LT-300 HDHEX2016-05-13
1535091945933154K160380LT-300 HDHEX2016-05-13
1535091922970326K150691Datalys Multi-Parameter Patient MonitorMWI2015-05-15
1535091545418546K143119LT-300 Video ColposcopeHEX2014-12-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HEX52017-05-21
MWI12015-05-15

PMN#

GUDID#

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