Cleared Traditional

INNOFLUOR QUINIDINE ASSAY SYSTEM

K955568 · Oxis Intl., Inc. · Toxicology
Apr 1996
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K955568 is an FDA 510(k) clearance for the INNOFLUOR QUINIDINE ASSAY SYSTEM, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on April 4, 1996, 120 days after receiving the submission on December 6, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K955568 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1995
Decision Date April 04, 1996
Days to Decision 120 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
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
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · Roche Diagnostic Systems, Inc. · Jul 1994