
Erika, Inc.
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ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF is an FDA 510(k)-cleared medical device (K833252) manufactured by Erika, Inc.. 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 December 13, 1983. Regulation: 8.