MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE

Control, Hemoglobin, Abnormal

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Modification To Abuscreen Online For Phencyclidine.

Pre-market Notification Details

Device IDK983704
510k NumberK983704
Device Name:MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
ClassificationControl, Hemoglobin, Abnormal
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 CodeJCM  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-21
Decision Date1999-02-10
Summary:summary

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