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FDA 510(k) Application Details - K102959
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K102959
Device Name
Electrode, Ion Specific, Sodium
Applicant
DIAMOND DIAGNOSTICS, INC.
333 FISKE ST.
HOLLISTON, MA 01746 US
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Contact
LIANN VOO
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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
10/05/2010
Decision Date
01/14/2011
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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