510(k) K991109

CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 by A.P. Total Care, Inc. — Product Code CGX

K991109 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02". The FDA issued a decision of Substantially Equivalent on May 25, 1999. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.