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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 K002855
Device Name BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
Applicant
Biocare Corp.
200 Prospect St.
Walham,  MA  02454
Applicant Contact PAUL W MCDONALD
Correspondent
Biocare Corp.
200 Prospect St.
Walham,  MA  02454
Correspondent Contact PAUL W MCDONALD
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JIH  
Date Received09/13/2000
Decision Date 10/12/2000
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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