510(k) K050652

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS by Arkray, Inc. — Product Code CGX

K050652 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "SPOTCHEM II CREATININE, AMYLASE & ALP TESTS". The FDA issued a decision of Substantially Equivalent on April 6, 2005. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Arkray, Inc. has at least 10 other 510(k) clearances on record.