510(k) K981003 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
| Applicant | International Medical Products, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 16, 1998 |
| Received | Mar 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2018 | Rockwell Medical, Inc DriSate Product Code DR-145
The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicar Terminated |
KPO | None listed |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-215); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | None listed |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240); 1 quart (0.95 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.