510(k) K053401

SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS by Arkray, Inc. — Product Code CIC

K053401 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS". The FDA issued a decision of Substantially Equivalent on March 24, 2006. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Arkray, Inc. has at least 10 other 510(k) clearances on record.