INNOFLOUR CALIBRATOR REAGENT SET

Calibrators, Drug Specific

OXIS INTL., INC.

The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for Innoflour Calibrator Reagent Set.

Pre-market Notification Details

Device IDK970509
510k NumberK970509
Device Name:INNOFLOUR CALIBRATOR REAGENT SET
ClassificationCalibrators, Drug Specific
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 CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-11
Decision Date1997-05-12
Summary:summary

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