Cleared Traditional

OLYMPUS CHLORID REAGENT, MODIFIED

K932528 · Olympus Corp. · Chemistry
Sep 1993
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K932528 is an FDA 510(k) clearance for the OLYMPUS CHLORID REAGENT, MODIFIED, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on September 17, 1993, 148 days after receiving the submission on April 22, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K932528 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1993
Decision Date September 17, 1993
Days to Decision 148 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