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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 K153730
Device Name ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
Applicant
Abbott Laboratories
Dept. 09aa, Bldg. Ap8, 100 Abbott Park Rd.
Abbott Park,  IL  60064 -6038
Applicant Contact Laura Yelvigi Joglekar
Correspondent
Abbott Laboratories
Dept. 09aa, Bldg. Ap8, 100 Abbott Park Rd.
Abbott Park,  IL  60064 -6038
Correspondent Contact Laura Yelvigi Joglekar
Regulation Number866.3830
Classification Product Code
LIP  
Subsequent Product Codes
JIT   JJX  
Date Received12/28/2015
Decision Date 06/15/2016
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
Predetermined Change
Control Plan Authorized		 No
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