Cleared Traditional

CHLORIDE REAGENT

K911297 · Intersect Systems, Inc. · Chemistry
Apr 1991
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K911297 is an FDA 510(k) clearance for the CHLORIDE REAGENT, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on April 16, 1991, 22 days after receiving the submission on March 25, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K911297 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1991
Decision Date April 16, 1991
Days to Decision 22 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