FDA 510(k) Applications for Medical Device Product Code "LCR"
(Fluorescent Immunoassay, Tobramycin)

FDA 510(k) Number Applicant Device Name Decision Date
K974029 CHIRON DIAGNOSTICS CORP. ACS TOBRAMYCIN 02/12/1998
K962818 DADE INTL., INC. TOBRAMYCIN FLEX REAGENT CARTRIDGE 09/13/1996
K060998 SERADYN, INC. QMS TOBRAMYCIN 07/21/2006


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