Cleared Traditional

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

K122126 · Randox Laboratories Limited · Chemistry
Aug 2012
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K122126 is an FDA 510(k) clearance for the DIRECT LDL/HDL CHOLESTEROL CALIBRATOR, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Randox Laboratories Limited (Crumlin, County Antrim, GA). The FDA issued a Cleared decision on August 14, 2012, 27 days after receiving the submission on July 18, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K122126 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2012
Decision Date August 14, 2012
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIS — Calibrator, Primary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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