Cleared Traditional

DETERMINATION OF QUINIDINE

K860049 · Clinical Data, Inc. · Toxicology
Jan 1986
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K860049 is an FDA 510(k) clearance for the DETERMINATION OF QUINIDINE, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on January 22, 1986, 16 days after receiving the submission on January 6, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K860049 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1986
Decision Date January 22, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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
ROCHE ONLINE TDM QUINIDINE
K032332 · Roche Diagnostics Corp. · Jan 2004
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