510(k) K051432

SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS by Arkray, Inc. — Product Code CIG

K051432 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS". The FDA issued a decision of Substantially Equivalent on June 17, 2005. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Arkray, Inc. has at least 10 other 510(k) clearances on record.