Cleared Traditional

OPUS PROCAINAMIDE TEST SYSTEM

K934762 · Pb Diagnostic Systems, Inc. · Toxicology
Jul 1994
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K934762 is an FDA 510(k) clearance for the OPUS PROCAINAMIDE TEST SYSTEM, a Enzyme Immunoassay, Procainamide (Class II — Special Controls, product code LAR), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 20, 1994, 289 days after receiving the submission on October 4, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K934762 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1993
Decision Date July 20, 1994
Days to Decision 289 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAR — Enzyme Immunoassay, Procainamide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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