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FDA 510(k) Application Details - K972526
Device Classification Name
Enzyme Immunoassay, Methadone
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510(K) Number
K972526
Device Name
Enzyme Immunoassay, Methadone
Applicant
DIAGNOSTIC REAGENTS, INC.
601 CALIFORNIA AVE.
SUNNYVALE, CA 94086 US
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Contact
YUH-GENG TSAY
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Regulation Number
862.3620
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Classification Product Code
DJR
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More FDA Info for this Product Code
Date Received
06/26/1997
Decision Date
08/04/1997
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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