Cleared Traditional

NAPA EIA ASSAY

K983812 · Diagnostic Reagents, Inc. · Toxicology
Nov 1998
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K983812 is an FDA 510(k) clearance for the NAPA EIA ASSAY, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 16, 1998, 19 days after receiving the submission on October 28, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K983812 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1998
Decision Date November 16, 1998
Days to Decision 19 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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