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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 K932674
Device Name CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
Applicant
Miles Inc., Dental Products
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact ROSANNE M SOVAL
Correspondent
Miles Inc., Dental Products
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact ROSANNE M SOVAL
Regulation Number862.2900
Classification Product Code
KQO  
Date Received06/02/1993
Decision Date 08/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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