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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K970509
Device Name INNOFLOUR CALIBRATOR REAGENT SET
Applicant
Oxis Intl., Inc.
6040 N. Cutter Cir., #317
Portland,  OR  97217 -3935
Applicant Contact LYNDA M TAYLOR
Correspondent
Oxis Intl., Inc.
6040 N. Cutter Cir., #317
Portland,  OR  97217 -3935
Correspondent Contact LYNDA M TAYLOR
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received02/11/1997
Decision Date 05/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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