Cleared Special

MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

K983697 · Roche Diagnostic Systems, Inc. · Toxicology
Dec 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K983697 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on December 11, 1998, 51 days after receiving the submission on October 21, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K983697 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1998
Decision Date December 11, 1998
Days to Decision 51 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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