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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 K890576
Device Name KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
Applicant
Kenlor Industries, Inc.
8130 Mcfadden Ave., Suite 105
Westminster,  CA  92683
Applicant Contact SOM, PH.D.
Correspondent
Kenlor Industries, Inc.
8130 Mcfadden Ave., Suite 105
Westminster,  CA  92683
Correspondent Contact SOM, PH.D.
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/06/1989
Decision Date 03/09/1989
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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