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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Quinidine
510(k) Number K955568
Device Name INNOFLUOR QUINIDINE ASSAY SYSTEM
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 Number862.3320
Classification Product Code
LBZ  
Date Received12/06/1995
Decision Date 04/04/1996
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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