FDA 510(k) Application Details - K973742

Device Classification Name Electrode, Ion-Specific, Chloride

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510(K) Number K973742
Device Name Electrode, Ion-Specific, Chloride
Applicant SENDX MEDICAL, INC.
1945 PALOMAR OAKS WAY
CARLSBAD, CA 92011 US
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Contact RUBEN CHAIREZ
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Regulation Number 862.1170

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Classification Product Code CGZ
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Date Received 10/01/1997
Decision Date 12/03/1997
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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