Cleared Traditional

CHOLESTEROL QVET

K943027 · Prisma Systems · Toxicology
Jan 1995
Decision
214d
Days
Class 1
Risk

About This 510(k) Submission

K943027 is an FDA 510(k) clearance for the CHOLESTEROL QVET, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on January 27, 1995, 214 days after receiving the submission on June 27, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K943027 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1994
Decision Date January 27, 1995
Days to Decision 214 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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