MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY is an FDA 510(k)-cleared medical device (K982709) manufactured by Alexon - Trend, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 1998. Regulation: 8.