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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Urine Leukocyte
510(k) Number K843727
Device Name LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
Applicant
Miles Laboratories, Inc.
P.O. Box 40
Elkhart,  IN  46515
Applicant Contact JOHN ENGLEMANN
Correspondent
Miles Laboratories, Inc.
P.O. Box 40
Elkhart,  IN  46515
Correspondent Contact JOHN ENGLEMANN
Regulation Number864.7675
Classification Product Code
LJX  
Date Received09/24/1984
Decision Date 01/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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