INNOFLUOR TOPIRAMATE CONTROL SET

Drug Specific Control Materials

OXIS INTL., INC.

The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for Innofluor Topiramate Control Set.

Pre-market Notification Details

Device IDK970517
510k NumberK970517
Device Name:INNOFLUOR TOPIRAMATE CONTROL SET
ClassificationDrug Specific Control Materials
Applicant OXIS INTL., INC. 6040 N. CUTTER CIRCLE, SUITE 317 Portland,  OR  97217 -3935
ContactLynda M Taylor
CorrespondentLynda M Taylor
OXIS INTL., INC. 6040 N. CUTTER CIRCLE, SUITE 317 Portland,  OR  97217 -3935
Product CodeLAS  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-11
Decision Date1997-05-12
Summary:summary

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