510(k) K950234

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 by Emd Chemicals, Inc. — Product Code CEK

K950234 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2". The FDA issued a decision of Substantially Equivalent on June 14, 1995. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.