Cleared Special

EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229

K011620 · Syva Co., Dade Behring, Inc. · Toxicology
Jun 2001
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K011620 is an FDA 510(k) clearance for the EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on June 18, 2001, 24 days after receiving the submission on May 25, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K011620 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2001
Decision Date June 18, 2001
Days to Decision 24 days
Submission Type Special
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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