
Diamond Diagnostics, Inc.
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DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS is an FDA 510(k)-cleared medical device (K133751) manufactured by Diamond Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2014. Regulation: 8.