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510(k) K843828

Device
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K843828
Product code
LFW  
Decision
Substantially Equivalent (SESE)
Decision date
1985-02-01
Date received
1984-09-28
Regulation
862.3900
Classification name
Fluorescence Polarization Immunoassay, Tobramycin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.1997-02-04
K944371TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORSigma Diagnostics, Inc.1994-11-10
K941614AXSYM TOBRAMYCINAbbott Laboratories1994-08-18
K912143CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp.1991-07-26
K900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.1990-04-20
K894531FPR TOBRAMYCIN KITColony Laboratories, Inc.1989-09-01
K872562INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETInnotron of Oregon, Inc.1987-08-17
K854392TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMUWindsor Laboratories, Inc.1985-12-05
K841866INNOFLOUR TOBRAMYCINInnotron Diagnostics1984-05-31

Legacy Summary#

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FDA Review#

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