ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT is an FDA 510(k)-cleared medical device (K971458) manufactured by Diagnostic Specialties. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 1, 1997. Regulation: 8.