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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K990439
Device Name CARESIDE CK
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 Number862.1215
Classification Product Code
JHS  
Date Received02/11/1999
Decision Date 04/19/1999
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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