Cleared Traditional

K842442 - AXIOM STABLE II URIC ACID TEST
(FDA 510(k) Clearance)

K842442 · Axiom, Inc. · Chemistry

Aug 1984

Decision

56d

Days

Class 1

Risk

K842442 is an FDA 510(k) clearance for the AXIOM STABLE II URIC ACID TEST. This device is classified as a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK).

Submitted by Axiom, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1984, 56 days after receiving the submission on June 21, 1984.

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

Submission Details

510(k) Number	K842442 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 1984
Decision Date	August 16, 1984
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—