FDA 510(k) Applications for Medical Device Product Code "KLR"
(Enzyme Immunoassay, Lidocaine)

FDA 510(k) Number Applicant Device Name Decision Date
K033809 DADE BEHRING, INC. DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D 02/20/2004
K973102 DIAGNOSTIC REAGENTS, INC. LIDOCAINE EIA ASSAY 09/12/1997
K032334 ROCHE DIAGNOSTICS CORP. ROCHE ONLINE TDM LIDOCAINE 01/12/2004
K090282 THERMO FISHER SCIENTIFIC INC. QMS LIDOCAINE 05/29/2009


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