510(k) K954527 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS
| Applicant | Rockwell Medical Supply, Wixom MI, US |
| Decision | Substantially Equivalent, Mar 1, 1996 |
| Received | Sep 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954527
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2008 | Rockwell Medical Technologies, Inc RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | None listed |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | None listed |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.