Cleared Traditional

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620

K071644 · Roche Diagnostics Corp. · Toxicology
Sep 2007
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K071644 is an FDA 510(k) clearance for the ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on September 12, 2007, 89 days after receiving the submission on June 15, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K071644 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2007
Decision Date September 12, 2007
Days to Decision 89 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLZ — Enzyme Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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