Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE

K912755 · Roche Diagnostic Systems, Inc. · Toxicology
Aug 1991
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K912755 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE, a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 26, 1991, 66 days after receiving the submission on June 21, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K912755 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1991
Decision Date August 26, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJP — Radioimmunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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