Cleared Traditional

ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT

K913414 · Roche Diagnostic Systems, Inc. · Toxicology
Sep 1991
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K913414 is an FDA 510(k) clearance for the ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT, a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on September 25, 1991, 62 days after receiving the submission on July 25, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K913414 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1991
Decision Date September 25, 1991
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAT — Radioimmunoassay, Cannabinoid(s)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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