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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 K872563
Device Name INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
Applicant
Innotron of Oregon, Inc.
4432 Se16th.Ave.
Portland,  OR  97202
Applicant Contact BUCK, PH.D
Correspondent
Innotron of Oregon, Inc.
4432 Se16th.Ave.
Portland,  OR  97202
Correspondent Contact BUCK, PH.D
Regulation Number862.3350
Classification Product Code
LGR  
Date Received06/24/1987
Decision Date 08/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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