FDA 510(k) Application Details - K153145

Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

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510(K) Number K153145
Device Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 US
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Contact Diana Dickson
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Regulation Number 866.3830

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Classification Product Code LIP
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Date Received 10/30/2015
Decision Date 07/05/2016
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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