Cleared Traditional

N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K971713 · Bayer Corp. · Toxicology
Jun 1997
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K971713 is an FDA 510(k) clearance for the N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 11, 1997, 33 days after receiving the submission on May 9, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K971713 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1997
Decision Date June 11, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

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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