Cleared Traditional

CHLORIDE QVET

K943006 · Prisma Systems · Chemistry
Dec 1994
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K943006 is an FDA 510(k) clearance for the CHLORIDE QVET, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 7, 1994, 167 days after receiving the submission on June 23, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K943006 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1994
Decision Date December 07, 1994
Days to Decision 167 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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