Cleared Abbreviated

Lumipulse G E2-III Calibrators

K163053 · Fujirebio Diagnostics,Inc. · Chemistry
Dec 2016
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K163053 is an FDA 510(k) clearance for the Lumipulse G E2-III Calibrators, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on December 1, 2016, 30 days after receiving the submission on November 1, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K163053 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2016
Decision Date December 01, 2016
Days to Decision 30 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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