HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION— 510(k) K012547
Substantially EquivalentDi-Chem, Inc.
FDA 510(k) clearance K012547 for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION, Substantially Equivalent on 2002-01-18. Applicant: Di-Chem, Inc.. Device class: 2.
Clearance details
- Applicant
- Di-Chem, Inc.
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Champlin, MN, US
Recent devices under product code KPO
view allMore clearances from Di-Chem, Inc.
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K012547
K-number listed on FDA's recall record- Z-3133-2026 — MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Z-1730-2025 — MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012547.
Data sourced from openFDA. This site is unofficial and independent of the FDA.