Cleared Traditional

LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

K142895 · Fujirebio Diagnostics,Inc. · Immunology
May 2015
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K142895 is an FDA 510(k) clearance for the LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on May 21, 2015, 230 days after receiving the submission on October 3, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K142895 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2014
Decision Date May 21, 2015
Days to Decision 230 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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