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FDA 510(k) Application Details - K153357
Device Classification Name
Electrode, Ion Specific, Sodium
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510(K) Number
K153357
Device Name
Electrode, Ion Specific, Sodium
Applicant
ABBOTT POINT OF CARE INC.
400 COLLEGE ROAD EAST
PRINCETON, NJ 08540 US
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Contact
MELISSA ROBINSON
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Regulation Number
862.1665
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Classification Product Code
JGS
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More FDA Info for this Product Code
Date Received
11/20/2015
Decision Date
07/08/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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