K253462
- 510(k) number
- K253462
- Device name
- NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Po
- Decision date
- 2026-01-29
- Date received
- 2025-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253462.pdf
Official FDA record: K253462
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.