510(k) K901229

CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) by Technicon Instruments Corp. — Product Code CGX

K901229 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)". The FDA issued a decision of Substantially Equivalent on May 4, 1990. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.