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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B637C25203210Citryte - Dry acid concentrate for bicarbonate dialysis, 2.0Ca / 3.0K, 45X, 25 Gallon800-847-2598info@dichem-us.com
B637C25302180Citryte - Dry acid concentrate for bicarbonate dialysis, 3.0Ca / 2.0K, 45X, 25 Gallons800-847-2598info@dichem-us.com
B637DB2151HEMO-LYTE - Dry sodium bicarbonate concentrate, 45X, 15gallon800-847-2598info@dichem-us.com
B637DB2211HEMO-LYTE - Dry sodium bicarbonate concentrate, 45X, 2.1gallons800-847-2598info@dichem-us.com
B637DB2251HEMO-LYTE - Dry sodium bicarbonate concentrate, 45X, 25gallons800-847-2598info@dichem-us.com
B637DBC6501HEMO-LYTE C - Dry sodium bicarbonate concentrate cartridge, 45X, 650grams800-847-2598info@dichem-us.com
B637DBC7201HEMO-LYTE C - Dry sodium bicarbonate concentrate cartridge, 45X, 720grams800-847-2598info@dichem-us.com
B637DBC7601HEMO-LYTE C - Dry sodium bicarbonate concentrate cartridge, 45X, 760grams800-847-2598info@dichem-us.com

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#

GUDID#

42 records. Showing 1-40. Next