Cleared Traditional

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES

K983698 · Roche Diagnostic Systems, Inc. · Toxicology
May 1999
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K983698 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE BARBITURATES, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on May 3, 1999, 194 days after receiving the submission on October 21, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K983698 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1998
Decision Date May 03, 1999
Days to Decision 194 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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