ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY is an FDA 510(k)-cleared medical device (K993706) manufactured by Roche Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 23, 2000. Regulation: 8.