INNOFLUOR QUINIDINE ASSAY SYSTEM

Enzyme Immunoassay, Quinidine

OXIS INTL., INC.

The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for Innofluor Quinidine Assay System.

Pre-market Notification Details

Device IDK955568
510k NumberK955568
Device Name:INNOFLUOR QUINIDINE ASSAY SYSTEM
ClassificationEnzyme Immunoassay, Quinidine
Applicant OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland,  OR  97217 -3935
ContactLynda M Taylor
CorrespondentLynda M Taylor
OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland,  OR  97217 -3935
Product CodeLBZ  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-06
Decision Date1996-04-04
Summary:summary

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