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510(k) K013451

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES by Phoenix Diagnostics, Inc. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2001
Date Received
October 18, 2001
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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