510(k) K022521 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
| Applicant | Rockwell Medical Technologies, Inc., Wixom MI, US |
| Decision | Substantially Equivalent, Jan 3, 2003 |
| Received | Jul 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2009 | Rockwell Medical Technologies, Inc SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure L Terminated |
KPO | None listed |
| Jan 5, 2009 | Rockwell Medical Technologies, Inc SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure L Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.