Cleared Traditional

ROCHE ONLINE TDM QUINIDINE

K032332 · Roche Diagnostics Corp. · Toxicology
Jan 2004
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K032332 is an FDA 510(k) clearance for the ROCHE ONLINE TDM QUINIDINE, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2004, 167 days after receiving the submission on July 29, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K032332 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2003
Decision Date January 12, 2004
Days to Decision 167 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LBZ — Enzyme Immunoassay, Quinidine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

Similar Devices — LBZ Enzyme Immunoassay, Quinidine

All 26
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
K052826 · Seradyn, Inc. · Dec 2005
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · Syva Co., Dade Behring, Inc. · Jun 2001
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · Bayer Corp. · Dec 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · Diagnostic Reagents, Inc. · Dec 1996
INNOFLUOR QUINIDINE ASSAY SYSTEM
K955568 · Oxis Intl., Inc. · Apr 1996
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · Roche Diagnostic Systems, Inc. · Jul 1994