FDA.reportPublic FDA data

510(k) K032334

Device
ROCHE ONLINE TDM LIDOCAINE
Applicant
ROCHE DIAGNOSTICS CORP.
510(k) number
K032334
Product code
KLR  
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-12
Date received
2003-07-29
Regulation
862.3555
Classification name
Enzyme Immunoassay, Lidocaine
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KLR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K090282QMS LIDOCAINEThermo Fisher Scientific, Inc.2009-05-29
K033809DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49DDade Behring, Inc.2004-02-20
K973102LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.1997-09-12
K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic Systems1988-06-20
K853010COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, Inc.1985-08-07
K843184STRATUS LIDOCAINE FLUOROMETRIC ENZYMEAmerican Dade1984-09-26
K833379LIDOCAINE ANALYTICAL TEST PACK ACAE.I. Dupont DE Nemours & Co., Inc.1983-12-27
K833381VALPROIC ACID ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.1983-12-27
K833623MODIF. OF EMIT CAD DISOPYRAMIDE ASSAYSyva Co.1983-12-08
K832799MODIFICA- OF EMIT CAD LIDOCAINE ASSAYSyva Co.1983-10-14
K831354EMIT QST LIDOCAINE ASSAYSyva Co.1983-05-27
K823887ADVANCE EMIT CAD DISOPYRAMIDE ASSAYSyva Co.1983-01-28
K823866ADVANCE EMIT CAD LIDOCAINE ASSAYSyva Co.1983-01-12
K822347LIDOCAINE FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.1982-08-25
K802131CYBREX LIDOCAINEAbbott Laboratories1980-10-31

Legacy Summary#

summary

FDA Review#

Decision Summary