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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K896440
Device Name KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
Applicant
Kenlor Industries, Inc.
9582 Hamliton Ave.
Suite 251
Huntington Beach,  CA  92646
Applicant Contact SOM, PH.D.
Correspondent
Kenlor Industries, Inc.
9582 Hamliton Ave.
Suite 251
Huntington Beach,  CA  92646
Correspondent Contact SOM, PH.D.
Regulation Number862.1645
Classification Product Code
JIR  
Date Received11/09/1989
Decision Date 02/16/1990
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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