Cleared Traditional

K860662 - AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
(FDA 510(k) Clearance)

K860662 · Amresco, Inc. · Chemistry
Mar 1986
Decision
18d
Days
Class 2
Risk

K860662 is an FDA 510(k) clearance for the AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on March 14, 1986, 18 days after receiving the submission on February 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K860662 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1986
Decision Date March 14, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code CHJ — Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170