FDA 510(k) Application Details - K010670

Device Classification Name Mercuric Thiocyanate, Colorimetry, Chloride

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510(K) Number K010670
Device Name Mercuric Thiocyanate, Colorimetry, Chloride
Applicant ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY, CA 94587 US
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Contact AMY LEVIN
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Regulation Number 862.1170

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Classification Product Code CHJ
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Date Received 03/06/2001
Decision Date 04/26/2001
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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