FDA 510(k) Applications for Medical Device Product Code "LFW"
(Fluorescence Polarization Immunoassay, Tobramycin)

FDA 510(k) Number Applicant Device Name Decision Date
K941614 ABBOTT LABORATORIES AXSYM TOBRAMYCIN 08/18/1994
K894531 COLONY LABORATORIES, INC. FPR TOBRAMYCIN KIT 09/01/1989
K841866 INNOTRON DIAGNOSTICS INNOFLOUR TOBRAMYCIN 05/31/1984
K872562 INNOTRON OF OREGON, INC. INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET 08/17/1987
K900707 INNOTRON OF OREGON, INC. MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR 04/20/1990
K912143 MICROGENICS CORP. CEDIA(R) TOBRAMYCIN ASSAY 07/26/1991
K843828 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA 02/01/1985
K964670 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN 02/04/1997
K944371 SIGMA DIAGNOSTICS, INC. TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR 11/10/1994
K854392 WINDSOR LABORATORIES, INC. TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU 12/05/1985


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact