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510(k) K002855

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER by Biocare Corp. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2000
Date Received
September 13, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

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