Cleared Traditional

LDL CHOLESTEROL (AUTOMATED)

K022519 · Jas Diagnostics, Inc. · Chemistry
Sep 2002
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K022519 is an FDA 510(k) clearance for the LDL CHOLESTEROL (AUTOMATED), a Colorimetric Method, Lipoproteins (Class I — General Controls, product code JHM), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on September 30, 2002, 62 days after receiving the submission on July 30, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K022519 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2002
Decision Date September 30, 2002
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHM — Colorimetric Method, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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