Cleared Traditional

KING DIAGNOSTICS CHLORIDE REAGENT

K922921 · King Diagnostics, Inc. · Chemistry
Oct 1992
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K922921 is an FDA 510(k) clearance for the KING DIAGNOSTICS CHLORIDE REAGENT, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 5, 1992, 110 days after receiving the submission on June 17, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K922921 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1992
Decision Date October 05, 1992
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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