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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K990036
Device Name CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
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 Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JJE  
Date Received01/06/1999
Decision Date 03/18/1999
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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