FDA 510(k) Application Details - K040973

Device Classification Name Electrode, Ion Specific, Urea Nitrogen

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510(K) Number K040973
Device Name Electrode, Ion Specific, Urea Nitrogen
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 862.1770

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Classification Product Code CDS
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Date Received 04/14/2004
Decision Date 12/27/2004
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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