Cleared Traditional

TDM N-ACETYLPROCAINAMIDE

K060738 · Roche Diagnostics Corp. · Toxicology
Aug 2006
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K060738 is an FDA 510(k) clearance for the TDM N-ACETYLPROCAINAMIDE, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on August 16, 2006, 149 days after receiving the submission on March 20, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K060738 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2006
Decision Date August 16, 2006
Days to Decision 149 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

Similar Devices — LAN Enzyme Immunoassay, N-acetylprocainamide

All 20
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · Dade Behring, Inc. · Oct 2003
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · Syva Co., Dade Behring, Inc. · Jun 2001
NAPA EIA ASSAY
K983812 · Diagnostic Reagents, Inc. · Nov 1998
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · Bayer Corp. · Jun 1997
AXSYM N-ACETYLPROCAINAMIDE
K955422 · Abbott Laboratories · Apr 1996
OPUS NAPA
K934705 · Pb Diagnostic Systems, Inc. · Nov 1993