Cleared Traditional

HDL CHOLESTEROL PLUS

K000568 · Roche Diagnostics Corp. · Chemistry
Aug 2000
Decision
164d
Days
Class 1
Risk

About This 510(k) Submission

K000568 is an FDA 510(k) clearance for the HDL CHOLESTEROL PLUS, a Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBT), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 4, 2000, 164 days after receiving the submission on February 22, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K000568 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2000
Decision Date August 04, 2000
Days to Decision 164 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LBT — Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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