The following data is part of a premarket notification filed by Di-chem, Inc. with the FDA for Hemo-lyte Hemodialysis Grade Sodium Bicarbonate Powder.
| Device ID | K012328 |
| 510k Number | K012328 |
| Device Name: | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DI-CHEM, INC. 12297 ENSIGN AVE. NORTH Champlin, MN 55316 |
| Contact | Keith A Buchholz |
| Correspondent | Keith A Buchholz DI-CHEM, INC. 12297 ENSIGN AVE. NORTH Champlin, MN 55316 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2002-01-18 |