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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 K892208
Device Name INNOFLUOR(TM) QUINIDINE 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 Number862.3320
Classification Product Code
LBZ  
Date Received04/03/1989
Decision Date 06/09/1989
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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