Cleared Traditional

HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL

K883942 · Icl Scientific · Toxicology
Nov 1988
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K883942 is an FDA 510(k) clearance for the HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Icl Scientific (Fountain Valley, US). The FDA issued a Cleared decision on November 10, 1988, 52 days after receiving the submission on September 19, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K883942 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1988
Decision Date November 10, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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