URIC ACID STANDARD, 8MG/DL #65078

URIC ACID STANDARD, 8MG/DL #65078 is an FDA 510(k)-cleared medical device (K823147) manufactured by Harleco Diagnostics. 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 November 21, 1982. Regulation: 8.