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FDA 510(k) Application Details - K023712
Device Classification Name
Enzyme Immunoassay, Amphetamine
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510(K) Number
K023712
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
ADVANTAGE DIAGNOSTICS CORP
764 SAN ALESO AVE.
SUNNYVALE, CA 94085 US
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Contact
JANIS FREESTONE
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Regulation Number
862.3100
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Classification Product Code
DKZ
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More FDA Info for this Product Code
Date Received
11/04/2002
Decision Date
01/31/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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