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FDA 510(k) Application Details - K051626
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K051626
Device Name
Enzyme Immunoassay, Opiates
Applicant
Immunalysis Corporation
829 TOWNE CENTER DR.
POMONA, CA 91767 US
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Contact
MICHAEL VINCENT
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Regulation Number
862.3650
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Classification Product Code
DJG
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More FDA Info for this Product Code
Date Received
06/20/2005
Decision Date
10/13/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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