Cleared Traditional

RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT

K131554 · Randox Laboratories, Ltd. · Chemistry

Jan 2014

Decision

224d

Days

Class 1

Risk

About This 510(k) Submission

K131554 is an FDA 510(k) clearance for the RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 9, 2014, 224 days after receiving the submission on May 30, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number	K131554 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2013
Decision Date	January 09, 2014
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2160