FDA.reportPublic FDA data

DI-CHEM, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21834152183415DI-CHEM, INC.1N2026-01-0112297 ENSIGN AVE. NORTH Champlin MN US 55316

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
764391500131184K901471GC-1000 THROUGH GC-3005 ACID CONCENTRATEKPO1990-07-27
764391519614991K823103DIALYSATE ADDITIVES-POWDER/LIQUIDKPO1982-11-17
764392000803861K202508Hemo-Lyte C CartridgeKPO2022-08-12
764391311302189K171015CitryteKPO2017-10-13
764391129854688K012547HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONKPO2002-01-18
764391401528554K012328HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDERKPO2002-01-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO62022-08-12

PMN#