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510(k) K003341

Device
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
Applicant
SYVA CO., DADE BEHRING, INC.
510(k) number
K003341
Product code
KLB  
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-22
Date received
2000-10-25
Regulation
862.3900
Classification name
Radioimmunoassay, Tobramycin
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL L ROGER
Address
P.O. Box 49013 3403 Yerba Buena Rd. San Jose CA US 95161 95161

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KLB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060853ONLINE TDM TOBRAMYCINRoche Diagnostics Corp.2006-06-09
K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)Diagnostic Products Corp.2001-08-20
K904304DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHODE.I. Dupont DE Nemours & Co., Inc.1990-10-26
K903192IL TOBRAMYCIN ASSAYInstrumentation Laboratory CO1990-08-22
K893913TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHODTechnicon Instruments Corp.1989-08-21
K882294EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAYSyva Co.1988-07-01
K874223EMIT TOBRAMYCIN ASSAYSyva Co.1987-11-13
K854184IN-VITRO TEST DETERMINATION OF TOBRAMYCINClinical Data, Inc.1985-12-04
K852671ACA TOBRAMY-CIN ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.1985-07-22
K832763TOBRAMYCIN REAGENTBiosan Laboratories, Inc.1984-03-23
K832985TOBRAMYCIN ANALYTICAL TEST PACK-ACAE.I. Dupont DE Nemours & Co., Inc.1983-10-27
K822858COAT-A-COUNT TOBRAMYCIN RIA KITDiagnostic Products Corp.1982-10-18
K813516MRI TOBRAMYCIN RIA KITMicroanalytic Research, Inc.1981-12-29
K812415KALLESTAD ANTISERA TO TOBRAMYCINKallestad Laboratories, Inc.1981-09-09
K810597MACRO-VUE CARD TESTBd Becton Dickinson Vacutainer Systems Preanalytic1981-03-17

Legacy Summary#

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FDA Review#

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