Cleared Traditional

ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES

K983174 · Roche Diagnostic Systems, Inc. · Toxicology
Nov 1998
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K983174 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1998, 69 days after receiving the submission on September 10, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K983174 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1998
Decision Date November 18, 1998
Days to Decision 69 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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