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FDA 510(k) Application Details - K992111
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K992111
Device Name
Enzyme Immunoassay, Opiates
Applicant
MEDTOX DIAGNOSTICS, INC.
1238 ANTHONY RD.
BURLINGTON, NC 27215 US
Other 510(k) Applications for this Company
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
06/22/1999
Decision Date
12/16/1999
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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