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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diazonium colorimetry, urobilinogen (urinary, non-quant.)
510(k) Number K852611
Device Name TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
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 Number862.1785
Classification Product Code
CDM  
Date Received06/19/1985
Decision Date 09/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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