510(k) K032377

ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID by Roche Diagnostics Corp. — Product Code KHS

K032377 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID". The FDA issued a decision of Substantially Equivalent on August 21, 2003. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.