FDA 510(k) Application Details - K022312

Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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510(K) Number K022312
Device Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY, CA 94587 US
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Contact ROBERT MILDER
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Regulation Number 862.1580

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Classification Product Code CEO
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Date Received 07/17/2002
Decision Date 09/05/2002
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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