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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 K873304
Device Name CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
Applicant
MILES LABORATORIES, INC.
1127 MYRTLE ST.
P.O. BOX 40
ELKHART,  IN  46514
Applicant Contact JOHN H ENGELMANN
Correspondent
MILES LABORATORIES, INC.
1127 MYRTLE ST.
P.O. BOX 40
ELKHART,  IN  46514
Correspondent Contact JOHN H ENGELMANN
Regulation Number864.7675
Classification Product Code
LJX  
Date Received08/18/1987
Decision Date 09/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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