Cleared Traditional

K812500 - ULTRACHEM URIC ACID ALDH, ITEM #65047
(FDA 510(k) Clearance)

K812500 · Harleco · Chemistry

Sep 1981

Decision

23d

Days

Class 1

Risk

K812500 is an FDA 510(k) clearance for the ULTRACHEM URIC ACID ALDH, ITEM #65047. This device is classified as a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 23 days after receiving the submission on August 31, 1981.

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

Submission Details

510(k) Number	K812500 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1981
Decision Date	September 23, 1981
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—