Cleared Traditional

Carbamazepine Gen 4

K151578 · Roche Diagnostics Operations (Rdo) · Toxicology
Oct 2015
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K151578 is an FDA 510(k) clearance for the Carbamazepine Gen 4, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on October 22, 2015, 133 days after receiving the submission on June 11, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K151578 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2015
Decision Date October 22, 2015
Days to Decision 133 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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