MACRALP(A) ENZYME IMMUNOASSAY KIT

MACRALP(A) ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K971157) manufactured by Strategic Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 14, 1998. Regulation: 8.