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FDA 510(k) Application Details - K023640
Device Classification Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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510(K) Number
K023640
Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant
ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY, CA 94587 US
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Contact
Dennis M Bleile
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Regulation Number
862.1475
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Classification Product Code
LBS
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More FDA Info for this Product Code
Date Received
10/30/2002
Decision Date
01/24/2003
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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