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FDA 510(k) Application Details - K061617
Device Classification Name
Enzyme Immunoassay, Amphetamine
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510(K) Number
K061617
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
3108 AVENIDA OLMEDA
CARLSBAD, CA 92009 US
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Contact
RODRIGO BERTIE
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Regulation Number
862.3100
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Classification Product Code
DKZ
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Date Received
06/09/2006
Decision Date
11/22/2006
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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