LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)

LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) is an FDA 510(k)-cleared medical device (K884424) manufactured by Bio-Rad. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 14, 1988. Regulation: 8.