Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112343
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
More FDA Info for this Device
510(K) Number
K112343
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVE
TARRYTOWN, NY 10591 US
Other 510(k) Applications for this Company
Contact
KIRA GORDON
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
08/15/2011
Decision Date
01/20/2012
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact