|
Device |
dialysate concentrate for hemodialysis (liquid or powder) |
Product Code | KPO |
Regulation Number |
876.5820
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
DI-CHEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
1. K191474 NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag) ...
|
2. K192017 Citrasate Liquid Acid Concentrate, NaturaLyte Liqu ...
|
3. K192209 Citrasate Dry Acid Concentrate, Granuflo Dry Acid ...
|
4. K212620 Citrasate Liquid Acid Concentrate, NaturaLyte Liqu ...
|
5. K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW ...
|
HAEMOPHARM BIOFLUIDS S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ISOPURE, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIPRO RENAL SOLUTIONS USA, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NXSTAGE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|