REVISED LABELING FOR LSD TEST KIT

Radioimmunoassay, Lsd (125-i)

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Revised Labeling For Lsd Test Kit.

Pre-market Notification Details

Device IDK874270
510k NumberK874270
Device Name:REVISED LABELING FOR LSD TEST KIT
ClassificationRadioimmunoassay, Lsd (125-i)
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley,  NJ  07110
ContactAdrienne Choma
CorrespondentAdrienne Choma
ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley,  NJ  07110
Product CodeDLB  
CFR Regulation Number862.3580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1987-11-13

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