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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K903338
Device Name KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
Applicant
Kenlor Industries, Inc.
9582 Hamliton Ave.
Suite 251
Huntington Beach,  CA  92646
Applicant Contact KAMALES SOM
Correspondent
Kenlor Industries, Inc.
9582 Hamliton Ave.
Suite 251
Huntington Beach,  CA  92646
Correspondent Contact KAMALES SOM
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/25/1990
Decision Date 09/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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