Cleared Traditional

ROCHE ONLINE THEOPHYLLINE

K020740 · Roche Diagnostics Corp. · Toxicology
Apr 2002
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K020740 is an FDA 510(k) clearance for the ROCHE ONLINE THEOPHYLLINE, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on April 16, 2002, 41 days after receiving the submission on March 6, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K020740 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2002
Decision Date April 16, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLS — Enzyme Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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