Cleared Traditional

MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE

K983704 · Roche Diagnostic Systems, Inc. · Toxicology
Feb 1999
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K983704 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE, a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 10, 1999, 112 days after receiving the submission on October 21, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K983704 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1998
Decision Date February 10, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JCM — Control, Hemoglobin, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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