SPOTCHEM II CREATININE, AMYLASE & ALP TESTS

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS is an FDA 510(k)-cleared medical device (K050652) manufactured by Arkray, 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 April 5, 2005. Regulation: 8.