510(k) K853244

TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE by Simmler, Inc. — Product Code CEK

K853244 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE". The FDA issued a decision of Substantially Equivalent on Aug 12, 1985. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Simmler, Inc. has 22 other 510(k) clearances on record.