Cleared Traditional

PROCAINAMIDE ENZYME IMMUNOASSAY

K962463 · Diagnostic Reagents, Inc. · Toxicology
Aug 1996
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K962463 is an FDA 510(k) clearance for the PROCAINAMIDE ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Procainamide (Class II — Special Controls, product code LAR), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 14, 1996, 50 days after receiving the submission on June 25, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K962463 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1996
Decision Date August 14, 1996
Days to Decision 50 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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