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FDA 510(k) Application Details - K040971
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K040971
Device Name
Electrode, Ion Specific, Sodium
Applicant
GENCHEM, INC.
471 W. LAMBERT RD., SUITE 107
BREA, CA 92821 US
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Contact
C.C. ALLAIN
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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
04/14/2004
Decision Date
12/22/2004
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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