Cleared Traditional

AXSYM N-ACETYLPROCAINAMIDE

K955422 · Abbott Laboratories · Toxicology
Apr 1996
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K955422 is an FDA 510(k) clearance for the AXSYM N-ACETYLPROCAINAMIDE, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 24, 1996, 148 days after receiving the submission on November 28, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K955422 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1995
Decision Date April 24, 1996
Days to Decision 148 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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