Medical Device Manufacturer · US , Wixom , MI

Rockwell Medical Technologies, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1999

Recent clearances: ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE, DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rockwell Medical Technologies, Inc. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Nov 17, 2006

ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE

Gastroenterology & Urology · 93d

Cleared Feb 28, 2003

ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE

Gastroenterology & Urology · 88d

Cleared Jan 03, 2003

BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON

Gastroenterology & Urology · 157d

Cleared Dec 23, 2002

DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE

Gastroenterology & Urology · 147d

Cleared Aug 05, 1999

DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE

Gastroenterology & Urology · 294d