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FDA 510(k) Application Details - K083680
Device Classification Name
Electrode, Ion Specific, Potassium
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510(K) Number
K083680
Device Name
Electrode, Ion Specific, Potassium
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
MC 00882
ROCHESTER, NY 14626-5101 US
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Contact
MARLENE A HANNA
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Regulation Number
862.1600
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Classification Product Code
CEM
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More FDA Info for this Product Code
Date Received
12/12/2008
Decision Date
02/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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