Cleared Traditional

OLYMPUS CHLORIDE REAGENT

K925338 · Olympus Corp. · Chemistry
Dec 1992
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K925338 is an FDA 510(k) clearance for the OLYMPUS CHLORIDE REAGENT, 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 December 11, 1992, 52 days after receiving the submission on October 20, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K925338 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1992
Decision Date December 11, 1992
Days to Decision 52 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

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