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FDA 510(k) Application Details - K102400
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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510(K) Number
K102400
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
DIAGNOSTICS DIRECT, LLC.
150 CHERRY LANE RD
EAST STROUDSBURG, PA 18301 US
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Contact
Gary Lehnus
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Regulation Number
866.3830
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Classification Product Code
LIP
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Date Received
08/24/2010
Decision Date
08/01/2011
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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