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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, Carbamazepine
510(k) Number K900702
Device Name MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
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 Number862.3645
Classification Product Code
LGI  
Date Received02/12/1990
Decision Date 04/12/1990
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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