Company ยท US
Rockwell Medical Technologies, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2006. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 12 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2006 | K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE Rockwell Medical Technologies, Inc. | KPO |
| Feb 28, 2003 | K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE Rockwell Medical Technologies, Inc. | KPO |
| Jan 3, 2003 | K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON Rockwell Medical Technologies, Inc. | KPO |
| Dec 23, 2002 | K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE Rockwell Medical Technologies, Inc. | KPO |
| Aug 5, 1999 | K983618 | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE Rockwell Medical Technologies, Inc. | KPO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K022521 |
| 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 | K022521 |
| 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 | K981003 |
| 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 | K981003 |
| 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 | K954527 |
| 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 | K954527 |
| 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 | K954527 |