ABUSCREEN ONLINE BENZ 200 CALIBRATORS

Calibrators, Drug Specific

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online Benz 200 Calibrators.

Pre-market Notification Details

Device IDK983555
510k NumberK983555
Device Name:ABUSCREEN ONLINE BENZ 200 CALIBRATORS
ClassificationCalibrators, Drug Specific
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
ContactMaria Feijoo
CorrespondentMaria Feijoo
ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-13
Decision Date1998-12-15
Summary:summary

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