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FDA 510(k) Application Details - K063866
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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510(K) Number
K063866
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
Bio-Rad Laboratories
6565 185TH AVE, NE
REDMOND, WA 98052 US
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DAVID BHEND
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Regulation Number
866.3830
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Classification Product Code
LIP
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Date Received
12/29/2006
Decision Date
03/19/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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