510(k) K012547 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
| Applicant | Di-Chem, Inc., Champlin MN, US |
| Decision | Substantially Equivalent, Jan 18, 2002 |
| Received | Aug 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation MedicaLyte Liquid Bicarbonate Concentrate
REF: BC-100 and BC+201 Open, Classified |
KPO | None listed |
| May 14, 2025 | Nipro Renal Soultions USA, Corporation 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). Open, Classified |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.