FDA.reportPublic FDA data

510(k) K032332

Device
ROCHE ONLINE TDM QUINIDINE
Applicant
ROCHE DIAGNOSTICS CORP.
510(k) number
K032332
Product code
LBZ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-12
Date received
2003-07-29
Regulation
862.3320
Classification name
Enzyme Immunoassay, Quinidine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MIKE FLIS
Address
9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LBZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.2005-12-23
K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.2001-06-12
K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.1996-12-24
K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1996-12-18
K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., Inc.1996-04-04
K941440COBAS-FP QUINIDINE REAGENTS AND CALIBRATORSRoche Diagnostic Systems, Inc.1994-07-06
K922913EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORSSyva Co.1992-08-24
K904990EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORSSyva Co.1991-02-04
K900705MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATORInnotron of Oregon, Inc.1990-04-12
K892208INNOFLUOR(TM) QUINIDINE REAGENT SETInnotron of Oregon, Inc.1989-06-09
K872175TDXR FLECAINIDEAbbott Laboratories1987-08-13
K864607EASY-TEST QUINIDINE ITEM NO. 67---/95Em Diagnostic Systems, Inc.1987-01-08
K862214EMIT QUINIDINE ASSAYSyva Co.1986-06-27
K860049DETERMINATION OF QUINIDINEClinical Data, Inc.1986-01-22
K850808COBAS FP REAGENTS FOR QUINIDINERoche Diagnostic Systems, Inc.1985-03-25

Legacy Summary#

summary

FDA Review#

Decision Summary