510(k) K160847
K160847 is an FDA 510(k) premarket notification submitted by Rockwell Medical for the device "Rockwell Medical CitraPure Acid Concetrate". The FDA issued a decision of Substantially Equivalent on October 20, 2016. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2016
- Date Received
- March 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type