The following data is part of a premarket notification filed by Di-chem, Inc. with the FDA for Hemo-lyte Hemodialysis Grade Sodium Bicarbonate Solution.
| Device ID | K012547 |
| 510k Number | K012547 |
| Device Name: | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION |
| 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 | 2001-08-07 |
| Decision Date | 2002-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817411021095 | K012547 | 000 |
| 10817411020261 | K012547 | 000 |
| 10817411020254 | K012547 | 000 |
| 10817411020247 | K012547 | 000 |
| 10817411022821 | K012547 | 000 |
| 10817411022814 | K012547 | 000 |