Cleared Abbreviated

Lumipulse G FSH-N Calibrators

K163534 · Fujirebio Diagnostics,Inc. · Chemistry
Jan 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K163534 is an FDA 510(k) clearance for the Lumipulse G FSH-N 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 January 13, 2017, 28 days after receiving the submission on December 16, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K163534 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2016
Decision Date January 13, 2017
Days to Decision 28 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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