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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Topiramatee
510(k) Number K970510
Device Name INNOFLOUR TOPIRAMATE REAGENT SET
Applicant
Oxis Intl., Inc.
6040 N. Cutter Cir., #317
Portland,  OR  97217
Applicant Contact LYNDA M TAYLOR
Correspondent
Oxis Intl., Inc.
6040 N. Cutter Cir., #317
Portland,  OR  97217
Correspondent Contact LYNDA M TAYLOR
Regulation Number862.3350
Classification Product Code
MSL  
Subsequent Product Code
DIP  
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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