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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
510(k) Number K955562
Device Name INNOFLUOR PHENYTOIN 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 Number862.3350
Classification Product Code
LGR  
Date Received12/06/1995
Decision Date 01/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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