Cleared Traditional

CHLORIDE

K883386 · Tech-Co, Inc. · Chemistry
Oct 1988
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K883386 is an FDA 510(k) clearance for the CHLORIDE, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on October 6, 1988, 57 days after receiving the submission on August 10, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K883386 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1988
Decision Date October 06, 1988
Days to Decision 57 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