FDA.reportPublic FDA data

GC Manufacturing America LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
GC Manufacturing America LLC5Y2026-01-013737 W 127th St Alsip IL US 60803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3506671789645005K993973FUJI II LC CAPSULEEBF2000-01-11
3506671194937158K961448FUJI IX GPEMA1996-07-08
3506671330170294K182854GC FujiCEM 2 (Improved)EMA2019-07-11
3506671249089107K102808MI VARNISHLBH2010-12-22
3506671266453867K070319GC FUJI IX GP EXTRAEMA2007-02-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EMA32019-07-11
LBH12010-12-22
EBF12000-01-11