FDA.reportPublic FDA data

510(k) K801084

Device
CYBREX GENTAMICIN
Applicant
Abbott Laboratories
510(k) number
K801084
Product code
LCQ
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-23
Date received
1980-05-07
Regulation
862.3450
Classification name
Fluorescent Immunoassay Gentamicin
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-Rad1997-08-06
K955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.1996-02-09
K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.1995-03-09
K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.1994-11-17
K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.1991-02-21
K904226'TDXFLX ANALYZERAbbott Laboratories1990-10-29
K894523FPR GENTAMICIN KITColony Laboratories, Inc.1989-09-28
K852158BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMABioprobe Intl., Inc.1985-06-25
K852013GENTAMICIN KIT(FPIA)Windsor Laboratories, Inc.1985-06-10
K843827COBAS REAGENTS FOR GENTAMICIN & CALIBRATRoche Diagnostic Systems, Inc.1985-02-01
K841865INNOFLOUR GENTAMICINInnotron Diagnostics1984-05-31
K841162IMMPULSE GENTAMICIN ASSAY REAGENTSParagon Diagnostics, Inc.1984-05-02
K820285SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAYSyva Co.1982-02-18
K813539GENTAMICIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.1981-12-31
K810942AMES TDA GENTAMICIN TESTMiles Laboratories, Inc.1981-04-17