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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K952840
Device Name KENLOR LIQUID TOTAL URINE CONTROL
Applicant
Kenlor Industries, Inc.
1560 E. Edinger Ave.,
Suite A-1
Santa Ana,  CA  92705
Applicant Contact KAMALES SOM
Correspondent
Kenlor Industries, Inc.
1560 E. Edinger Ave.,
Suite A-1
Santa Ana,  CA  92705
Correspondent Contact KAMALES SOM
Regulation Number862.1660
Classification Product Code
JJW  
Date Received06/21/1995
Decision Date 07/19/1995
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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