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510(k) K020148

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems by Phoenix Diagnostics, Inc. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2002
Date Received
January 16, 2002
Clearance Type
Traditional
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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