Cleared Traditional

340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER

K945408 · Catachem, Inc. · Chemistry
Feb 1995
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K945408 is an FDA 510(k) clearance for the 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Catachem, Inc. (Bridgeport, US). The FDA issued a Cleared decision on February 22, 1995, 111 days after receiving the submission on November 3, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K945408 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1994
Decision Date February 22, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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