Cleared Traditional

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

K153730 · Abbott Laboratories · Microbiology

Jun 2016

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K153730 is an FDA 510(k) clearance for the ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 15, 2016, 170 days after receiving the submission on December 28, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number	K153730 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2015
Decision Date	June 15, 2016
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF