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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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