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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 K790965
Device Name REAGENT STRIPS FOR URINALYSIS
Applicant
MILES LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MILES LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1785
Classification Product Code
CDM  
Date Received05/22/1979
Decision Date 06/28/1979
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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