
Rockwell Medical
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Rockwell Medical CitraPure Acid Concetrate is an FDA 510(k)-cleared medical device (K160847) manufactured by Rockwell Medical. 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 October 19, 2016. Regulation: 8.