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FDA 510(k) Application Details - K112995
Device Classification Name
Electrode, Ion Specific, Potassium
More FDA Info for this Device
510(K) Number
K112995
Device Name
Electrode, Ion Specific, Potassium
Applicant
INSTRUMENTATION LABORATORY CO.
526 ROUTE 303
ORANGEBURG, NY 10962 US
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Contact
CARL MARBLE
Other 510(k) Applications for this Contact
Regulation Number
862.1600
More FDA Info for this Regulation Number
Classification Product Code
CEM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2011
Decision Date
05/03/2012
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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