ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME is an FDA 510(k)-cleared medical device (K853951) manufactured by Behring Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 1986. Regulation: 8.