ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE— 510(k) K062399
Substantially EquivalentRockwell Medical Technologies, Inc.
FDA 510(k) clearance K062399 for ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE, Substantially Equivalent on 2006-11-17. Applicant: Rockwell Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Rockwell Medical Technologies, Inc.
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wixom, MI, US
Recent devices under product code KPO
view allMore clearances from Rockwell Medical Technologies, Inc.
view all- K023985 — ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
- K022521 — BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
- K022500 — DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
- K983618 — DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
Adverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.