
Fresenius Medical Care Renal Therapies Group, LLC
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NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is an FDA 510(k)-cleared medical device (K253462) manufactured by Fresenius Medical Care Renal Therapies Group, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 2026. Regulation: 8.