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510(k) K060108

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 by Roche Diagnostics Corp. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2006
Date Received
January 13, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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