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FDA 510(k) Application Details - K102647
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K102647
Device Name
Electrode, Ion Specific, Sodium
Applicant
ELITECHGROUP VITAL SCIENTIFIC BV
21720 23RD DR SE
SUITE 150
BOTHELL, WA 98021 US
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Contact
DEBRA K HUTSON
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
09/14/2010
Decision Date
03/24/2011
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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