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FDA 510(k) Application Details - K023617
Device Classification Name
Enzyme Immunoassay, Methadone
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510(K) Number
K023617
Device Name
Enzyme Immunoassay, Methadone
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT, CA 94538 US
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Contact
LAKSHMI ANNE
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Regulation Number
862.3620
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Classification Product Code
DJR
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Date Received
10/29/2002
Decision Date
08/27/2003
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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