Cleared Traditional

ROCHE ONLINE TDM PHENYTOIN

K030428 · Roche Diagnostics Corp. · Toxicology
Apr 2003
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K030428 is an FDA 510(k) clearance for the ROCHE ONLINE TDM PHENYTOIN, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 28, 2003, 77 days after receiving the submission on February 10, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K030428 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2003
Decision Date April 28, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIP — Enzyme Immunoassay, Diphenylhydantoin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350

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