Cleared Traditional

K832438 - CHLORIDE REAGENT SET
(FDA 510(k) Clearance)

K832438 · Amresco, Inc. · Chemistry

Jan 1984

Decision

179d

Days

Class 2

Risk

K832438 is an FDA 510(k) clearance for the CHLORIDE REAGENT SET. This device is classified as a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ).

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 20, 1984, 179 days after receiving the submission on July 25, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number	K832438 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1983
Decision Date	January 20, 1984
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—