Cleared Traditional

CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA

K080623 · Jas Diagnostics, Inc. · Chemistry
Nov 2008
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K080623 is an FDA 510(k) clearance for the CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 17, 2008, 257 days after receiving the submission on March 5, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K080623 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2008
Decision Date November 17, 2008
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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