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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 K012829
Device Name STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
Applicant
Biocare Corp.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact BRUCE A MACFARLAND
Correspondent
Biocare Corp.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact BRUCE A MACFARLAND
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
JIL   JIO  
Date Received08/23/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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