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FDA 510(k) Application Details - K161216
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K161216
Device Name
Enzyme Immunoassay, Opiates
Applicant
IMMUNALYSIS CORPORATION
829 TOWNE CENTER DRIVE
POMONA, CA 91767 US
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Contact
Joseph Ginete
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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
04/29/2016
Decision Date
06/14/2017
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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