FDA.reportPublic FDA data

ROCKWELL MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16521763003463852ROCKWELL MEDICAL1N2026-01-014051 Freeport Pkwy Ste 100 GRAPEVINE TX US 76051
18354983001236991ROCKWELL MEDICAL1N2026-01-0130142 WIXOM RD. WIXOM MI US 48393
19543153002970979ROCKWELL MEDICAL1N2026-01-01308 N Iowa Ave WASHINGTON IA US 52353
10658473003040753ROCKWELL MEDICAL1N2020-04-25604 High Tech Ct GREER SC US 29650

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
171951788000063K983618DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATEKPO1999-08-05
171981788000063K983618DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATEKPO1999-08-05
171961788000063K983618DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATEKPO1999-08-05
171971788000063K983618DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATEKPO1999-08-05
171951095408208K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXESKPO1998-06-16
171971095408208K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXESKPO1998-06-16
171961095408208K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXESKPO1998-06-16
171951277372599K973253ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATEKPO1997-10-30
171971277372599K973253ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATEKPO1997-10-30
171961277372599K973253ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATEKPO1997-10-30
171971478441079K971053ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSISKPO1997-06-16
171951478441079K971053ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSISKPO1997-06-16
171961478441079K971053ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSISKPO1997-06-16
171951544262669K954527ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERSKPO1996-03-01
171971544262669K954527ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERSKPO1996-03-01
171961544262669K954527ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERSKPO1996-03-01
171951298512460K221652NIKKICARTKPO2023-03-03
171971298512460K221652NIKKICARTKPO2023-03-03
171961672185258K160847Rockwell Medical CitraPure Acid ConcetrateKPO2016-10-20
171951672185258K160847Rockwell Medical CitraPure Acid ConcetrateKPO2016-10-20
171971672185258K160847Rockwell Medical CitraPure Acid ConcetrateKPO2016-10-20
171961727632335K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693FJK2007-10-04
171971727632335K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693FJK2007-10-04
171951727632335K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693FJK2007-10-04
171961544173595K062399ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPUREKPO2006-11-17
171971544173595K062399ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPUREKPO2006-11-17
171951544173595K062399ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPUREKPO2006-11-17
171981496674012K022521BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLONKPO2003-01-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO252023-03-03
FJK32007-10-04

PMN#

Applications#

GUDID#

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