Cleared Abbreviated

Lumipulse G LH Calibrators

K163521 · Fujirebio Diagnostics,Inc. · Chemistry
Jan 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K163521 is an FDA 510(k) clearance for the Lumipulse G LH 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 12, 2017, 28 days after receiving the submission on December 15, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K163521 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2016
Decision Date January 12, 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

Similar Devices — JIT Calibrator, Secondary

All 244
VITROS Immunodiagnostic Products Insulin Calibrators
K171168 · Ortho-Clinical Diagnostics · May 2017
CalSet IGF-1
K170938 · Roche Diagnostics · Apr 2017
Abbott ARCHITECT Free T3
K170160 · Abbott Laboratories · Feb 2017
Lumipulse G FSH-N Calibrators
K163534 · Fujirebio Diagnostics,Inc. · Jan 2017
Lumipulse G Progesterone-N Calibrators
K163546 · Fujirebio Diagnostics,Inc. · Jan 2017
Lumipulse G Prolactin
K163544 · Fujirebio Diagnostics,Inc. · Jan 2017