510(k) K980996

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) by Roche Diagnostic Systems, Inc. — Product Code KHS

K980996 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)". The FDA issued a decision of Substantially Equivalent on June 5, 1998. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.