Cleared Traditional

Lumipulse G TP-N Immunoreaction Cartridge Set

K153145 · Fujirebio Diagnostics,Inc. · Microbiology
Jul 2016
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K153145 is an FDA 510(k) clearance for the Lumipulse G TP-N Immunoreaction Cartridge Set, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on July 5, 2016, 249 days after receiving the submission on October 30, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K153145 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2015
Decision Date July 05, 2016
Days to Decision 249 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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