Cleared Traditional

SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL

K042443 · Arkray, Inc. · Chemistry
Nov 2004
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K042443 is an FDA 510(k) clearance for the SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on November 24, 2004, 76 days after receiving the submission on September 9, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K042443 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2004
Decision Date November 24, 2004
Days to Decision 76 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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