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510(k) K903192

Device
IL TOBRAMYCIN ASSAY
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K903192
Product code
KLB  
Decision
Substantially Equivalent (SESE)
Decision date
1990-08-22
Date received
1990-07-19
Regulation
862.3900
Classification name
Radioimmunoassay, Tobramycin
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEORGE A LYNA
Address
113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K003341EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.2001-01-22
K904304DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHODE.I. Dupont DE Nemours & Co., Inc.1990-10-26
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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