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FDA 510(k) Application Details - K052520
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K052520
Device Name
Enzyme Immunoassay, Opiates
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
3108 AVENIDA OLMEDA
CARLSBAD, CA 92009 US
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Contact
RODRIGO BERLIE
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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
09/14/2005
Decision Date
04/24/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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