ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)

Enzyme Immunoassay, Cannabinoids

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 For Cannabinoids (100 Test Kit).

Pre-market Notification Details

Device IDK981584
510k NumberK981584
Device Name:ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
ContactRita Smith
CorrespondentRita Smith
ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
Product CodeLDJ  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-04
Decision Date1998-05-28
Summary:summary

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