COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS

Cresolphthalein Complexone, Calcium

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 Reagent Cassettes & Ancillary Reagents.

Pre-market Notification Details

Device IDK963292
510k NumberK963292
Device Name:COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
ClassificationCresolphthalein Complexone, Calcium
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
ContactAndrea Casper
CorrespondentAndrea Casper
ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
Product CodeCIC  
Subsequent Product CodeDBF
Subsequent Product CodeDDQ
Subsequent Product CodeDDR
Subsequent Product CodeDHR
Subsequent Product CodeJBQ
Subsequent Product CodeJIT
Subsequent Product CodeJJX
Subsequent Product CodeJJY
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-21
Decision Date1996-10-31
Summary:summary

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