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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 K895827
Device Name INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
Applicant
Innotron of Oregon, Inc.
4432 SE16th.Ave.
Portland,  OR  97202
Applicant Contact CRAIG SMART
Correspondent
Innotron of Oregon, Inc.
4432 SE16th.Ave.
Portland,  OR  97202
Correspondent Contact CRAIG SMART
Regulation Number862.3350
Classification Product Code
LGR  
Date Received10/02/1989
Decision Date 10/31/1989
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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