Cleared Traditional

K832439 - CREATININE REAGENT SET
(FDA 510(k) Clearance)

K832439 · Amresco, Inc. · Chemistry

Jan 1984

Decision

176d

Days

Class 2

Risk

K832439 is an FDA 510(k) clearance for the CREATININE REAGENT SET. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX).

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984, 176 days after receiving the submission on July 25, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K832439 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1983
Decision Date	January 17, 1984
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—