LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) is an FDA 510(k)-cleared medical device (K880495) 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 March 14, 1988. Regulation: 8.