Cleared Traditional

ABUSCREEN ONLINE BENZ 300 CALIBRATORS

K983556 · Roche Diagnostic Systems, Inc. · Toxicology
Dec 1998
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K983556 is an FDA 510(k) clearance for the ABUSCREEN ONLINE BENZ 300 CALIBRATORS, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on December 15, 1998, 63 days after receiving the submission on October 13, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K983556 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1998
Decision Date December 15, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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