Cleared Traditional

Lumipulse G CA15-3

K192524 · Fujirebio Diagnostics,Inc. · Immunology
Sep 2020
Decision
357d
Days
Class 2
Risk

About This 510(k) Submission

K192524 is an FDA 510(k) clearance for the Lumipulse G CA15-3, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 4, 2020, 357 days after receiving the submission on September 13, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K192524 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2019
Decision Date September 04, 2020
Days to Decision 357 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOI — System, Test, Immunological, Antigen, Tumor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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