Cleared Traditional

K971133 - URIC, UA, OR URIC ACID
(FDA 510(k) Clearance)

K971133 · Carolina Liquid Chemistries Corp. · Chemistry

Apr 1997

Decision

18d

Days

Class 1

Risk

K971133 is an FDA 510(k) clearance for the URIC, UA, OR URIC ACID. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK).

Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on April 14, 1997, 18 days after receiving the submission on March 27, 1997.

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

Submission Details

510(k) Number	K971133 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1997
Decision Date	April 14, 1997
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement