Cleared Traditional

OLYMPUS CHLORIDE REAGENT, MODIFICATION

K934136 · Olympus Corp. · Chemistry
Nov 1993
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K934136 is an FDA 510(k) clearance for the OLYMPUS CHLORIDE REAGENT, MODIFICATION, 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 November 5, 1993, 78 days after receiving the submission on August 19, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K934136 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1993
Decision Date November 05, 1993
Days to Decision 78 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