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FDA 510(k) Application Details - K031759
Device Classification Name
Enzyme Immunoassay, Amphetamine
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510(K) Number
K031759
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
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Contact
EDWARD TUNG
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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
06/06/2003
Decision Date
08/04/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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