Cleared Traditional

OPUS NAPA

K934705 · Pb Diagnostic Systems, Inc. · Toxicology
Nov 1993
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K934705 is an FDA 510(k) clearance for the OPUS NAPA, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on November 22, 1993, 53 days after receiving the submission on September 30, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K934705 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1993
Decision Date November 22, 1993
Days to Decision 53 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAN — Enzyme Immunoassay, N-acetylprocainamide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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