COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)

Enzymatic, Carbon-dioxide

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Integra Carbon Dioxide (co2-s), Cobas Integra Glucose Hk Liquid (glulf).

Pre-market Notification Details

Device IDK980996
510k NumberK980996
Device Name:COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
ClassificationEnzymatic, Carbon-dioxide
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
ContactJames W Haynes
CorrespondentJames W Haynes
ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-17
Decision Date1998-06-05
Summary:summary

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