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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K903101
Device Name INNOFLUOR (TM) AMIKACIN CALIBRATOR 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 Number862.3200
Classification Product Code
DLJ  
Date Received07/13/1990
Decision Date 08/22/1990
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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