Cleared Traditional

PRIMIDONE EIA TEST

K960526 · Diagnostic Reagents, Inc. · Toxicology
Mar 1996
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K960526 is an FDA 510(k) clearance for the PRIMIDONE EIA TEST, a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 18, 1996, 41 days after receiving the submission on February 6, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K960526 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1996
Decision Date March 18, 1996
Days to Decision 41 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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