Cleared Traditional

K024014 - RANDOX RX DAYTONA (FDA 510(k) Clearance)

K024014 · Randox Laboratories, Ltd. · Chemistry device
Dec 2003
Decision
365d
Days
Class 2
Risk

K024014 is an FDA 510(k) clearance for the RANDOX RX DAYTONA. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on December 4, 2003, 365 days after receiving the submission on December 4, 2002.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K024014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date December 04, 2003
Days to Decision 365 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1345