Cleared Traditional

K923503 - URIC ACID ENZYMATIC COLORIMERIC KIT (FDA 510(k) Clearance)

K923503 · Randox Laboratories, Ltd. · Chemistry device

Jul 1993

Decision

372d

Days

Class 1

Risk

K923503 is an FDA 510(k) clearance for the URIC ACID ENZYMATIC COLORIMERIC KIT. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I - General Controls, product code KNK).

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on July 22, 1993, 372 days after receiving the submission on July 15, 1992.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number	K923503 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 1992
Decision Date	July 22, 1993
Days to Decision	372 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	KNK — Acid, Uric, Uricase (colorimetric)
Device Class	Class I - General Controls
CFR Regulation	21 CFR 862.1775