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FDA 510(k) Application Details - K093175
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K093175
Device Name
Enzyme Immunoassay, Opiates
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
1 CONGRESSIONAL DRIVE
APT C,
GREENVILLE, DE 19807 US
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Contact
HOWARD MANN
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Regulation Number
862.3650
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Classification Product Code
DJG
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Date Received
10/08/2009
Decision Date
08/25/2010
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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