Cleared Traditional

Lumipulse G TSH-III Immunoreaction Cartridges

K171103 · Fujirebio Diagnostics,Inc. · Chemistry
Jul 2017
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K171103 is an FDA 510(k) clearance for the Lumipulse G TSH-III Immunoreaction Cartridges, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on July 28, 2017, 106 days after receiving the submission on April 13, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K171103 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2017
Decision Date July 28, 2017
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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