Cleared Traditional

LIGHTCYCLER INSTRUMENT VERSION 1.2

K033734 · Roche Diagnostics Corp. · Chemistry
Dec 2003
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K033734 is an FDA 510(k) clearance for the LIGHTCYCLER INSTRUMENT VERSION 1.2, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on December 17, 2003, 19 days after receiving the submission on November 28, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K033734 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2003
Decision Date December 17, 2003
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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