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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 K872142
Device Name INNOFLUOR PHENYTOIN CALIBRATOR SET
Applicant
Innotron of Oregon, Inc.
4432 SE16th.Ave.
Portland,  OR  97202
Applicant Contact BUCK, PHD
Correspondent
Innotron of Oregon, Inc.
4432 SE16th.Ave.
Portland,  OR  97202
Correspondent Contact BUCK, PHD
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received06/03/1987
Decision Date 07/21/1987
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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