Cleared Traditional

ONLINE TDM CARBAMAZEPINE

K031902 · Roche Diagnostics Corp. · Toxicology
Sep 2003
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K031902 is an FDA 510(k) clearance for the ONLINE TDM CARBAMAZEPINE, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on September 17, 2003, 89 days after receiving the submission on June 20, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K031902 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2003
Decision Date September 17, 2003
Days to Decision 89 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLT — Enzyme Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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