SYVA ADVANCE STANDARDIZATION KIT 01

SYVA ADVANCE STANDARDIZATION KIT 01 is an FDA 510(k)-cleared medical device (K820698) manufactured by Syva Co.. 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 March 31, 1982. Regulation: 8.