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FDA 510(k) Application Details - K091361
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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510(K) Number
K091361
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
6695 RIVER CREST POINT
SUWANEE, GA 30024 US
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Contact
CAROLYN K GEORGE
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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
05/08/2009
Decision Date
12/16/2009
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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