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. AP 8, |
100 Abbott Park Road |
Abbott Park,
IL
60064 -6038
|
|
Applicant Contact |
Laura Yelvigi Joglekar |
Correspondent |
Abbott Laboratories |
Dept 09AA, Bldg. AP 8, |
100 Abbott Park Road |
Abbott Park,
IL
60064 -6038
|
|
Correspondent Contact |
Laura Yelvigi Joglekar |
Regulation Number | 866.3830
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/28/2015 |
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
|
|
|