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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated urinalysis system
510(k) Number K761306
Device Name CLINILAB AUTOMATED URINALYSIS SYSTEM
Applicant
MILES LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MILES LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2900
Classification Product Code
KQO  
Date Received12/22/1976
Decision Date 03/21/1977
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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