FDA.reportPublic FDA data

510(k) K822347

Device
LIDOCAINE FLUORESCENT IMMUNOASSAY
Applicant
AMERICAN DIAGNOSTIC CORP.
510(k) number
K822347
Product code
KLR  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-25
Date received
1982-08-06
Regulation
862.3555
Classification name
Enzyme Immunoassay, Lidocaine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K032334ROCHE ONLINE TDM LIDOCAINERoche Diagnostics Corp.2004-01-12
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
K802131CYBREX LIDOCAINEAbbott Laboratories1980-10-31

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases