Cleared Traditional

MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES

K983702 · Roche Diagnostic Systems, Inc. · Toxicology
Feb 1999
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K983702 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 11, 1999, 113 days after receiving the submission on October 21, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K983702 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1998
Decision Date February 11, 1999
Days to Decision 113 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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