Cleared Traditional

ONLINE DAT Benzodiazepines II

K221765 · Roche Diagnostics · Toxicology
Dec 2022
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K221765 is an FDA 510(k) clearance for the ONLINE DAT Benzodiazepines II, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on December 23, 2022, 189 days after receiving the submission on June 17, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K221765 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2022
Decision Date December 23, 2022
Days to Decision 189 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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