Cleared Traditional

DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS

K983159 · Diagnostic Reagents, Inc. · Toxicology
Nov 1998
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K983159 is an FDA 510(k) clearance for the DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 5, 1998, 57 days after receiving the submission on September 9, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K983159 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1998
Decision Date November 05, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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