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FDA 510(k) Application Details - K160225
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K160225
Device Name
Electrode, Ion Specific, Sodium
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD, MA 01730 US
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Contact
CAROL MARBLE
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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
01/29/2016
Decision Date
12/14/2016
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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