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FDA 510(k) Application Details - K093837
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
More FDA Info for this Device
510(K) Number
K093837
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
ZEUS SCIENTIFIC, INC. (ZEUS)
P.O. BOX 38
RARITAN, NJ 08869 US
Other 510(k) Applications for this Company
Contact
EWA NADOLCZAK
Other 510(k) Applications for this Contact
Regulation Number
866.3830
More FDA Info for this Regulation Number
Classification Product Code
LIP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2009
Decision Date
10/01/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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