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FDA 510(k) Application Details - K014233
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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510(K) Number
K014233
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
TRINITY BIOTECH, PLC
IDA BUSINESS PARK BRAY
CO. WICKLOW IE
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Contact
FIONA CAMPBELL
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Regulation Number
866.3830
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Classification Product Code
LIP
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More FDA Info for this Product Code
Date Received
12/26/2001
Decision Date
01/24/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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