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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K112343
Device Name TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVE
TARRYTOWN,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVE
TARRYTOWN,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number866.3830
Classification Product Code
LIP  
Date Received08/15/2011
Decision Date 01/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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