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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K990024
Device Name CARESIDE ALKALINE PHOSPHATASE
Applicant
Careside, Inc.
6100 Bristol Pkwy.
Culver City,  CA  90230
Applicant Contact KENNETH B ASARCH
Correspondent
Careside, Inc.
6100 Bristol Pkwy.
Culver City,  CA  90230
Correspondent Contact KENNETH B ASARCH
Regulation Number862.1050
Classification Product Code
CJE  
Date Received01/05/1999
Decision Date 01/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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