
Breem Laboratories
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HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS is an FDA 510(k)-cleared medical device (K860336) manufactured by Breem Laboratories. 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 March 3, 1986. Regulation: 8.