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FDA 510(k) Application Details - K121140
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K121140
Device Name
Electrode, Ion Specific, Sodium
Applicant
DIAMOND DIAGNOSTICS, INC
333 Fiske St
Holliston, MA 01746 US
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Contact
KATHY CRUZ
Other 510(k) Applications for this Contact
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
04/16/2012
Decision Date
08/22/2012
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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