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FDA 510(k) Application Details - K051958
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K051958
Device Name
Enzyme Immunoassay, Opiates
Applicant
MP BIOMEDICALS, LLC.
9418 LASAINE AVE.
NORTHRIDGE, CA 91325 US
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Contact
ROBIN J HELLEN
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Regulation Number
862.3650
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Classification Product Code
DJG
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Date Received
07/19/2005
Decision Date
07/21/2006
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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