ABUSCREEN ONLINE(R) CALIBRATORS

Colorimetry, Salicylate

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(r) Calibrators.

Pre-market Notification Details

Device IDK946000
510k NumberK946000
Device Name:ABUSCREEN ONLINE(R) CALIBRATORS
ClassificationColorimetry, Salicylate
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 CodeDKJ  
CFR Regulation Number862.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-06
Decision Date1995-01-25

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