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FDA 510(k) Application Details - K041747
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K041747
Device Name
Enzyme Immunoassay, Opiates
Applicant
LIFEPOINT,INC
1205 SOUTH DUPONT ST.
ONTARIO, CA 91761 US
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Contact
DAVID B GOLDBERG
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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
06/29/2004
Decision Date
11/24/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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