FDA 510(k) Applications for Medical Device Product Code "LGR"
(Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total))

FDA 510(k) Number Applicant Device Name Decision Date
K935375 ABBOTT LABORATORIES AXSYM PHENYTOIN ASSAY 06/21/1994
K953840 ABBOTT LABORATORIES AXSYM PHENYTOIN II 09/25/1995
K946328 ABBOTT LABORATORIES TDX(R)/TDXFLX(R) PHENYTOIN II 03/28/1995
K844171 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE 12/10/1984
K955873 CIBA CORNING DIAGNOSTICS CORP. ACS PHENYTOIN ASSAY 03/11/1996
K841706 INNOTRON DIAGNOSTICS INNOFLUOR PHENYTOIN 05/22/1984
K895827 INNOTRON OF OREGON, INC. INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET 10/31/1989
K872563 INNOTRON OF OREGON, INC. INNOTRON INNOFLUOR PHEYTOIN REAGENT SET 08/21/1987
K955562 OXIS INTL., INC. INNOFLUOR PHENYTOIN ASSAY SYSTEM 01/24/1996
K896868 PB DIAGNOSTIC SYSTEMS, INC. OPUS PHENYTOIN TEST SYSTEM 01/02/1990
K843824 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS FP REAGENTS FOR PHENYTOIN & CALIBR 02/01/1985
K936131 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS 03/11/1994
K862554 SCLAVO, INC. IMMPULSE PHENYTOIN ASSAY REAGENT 07/16/1986
K943313 SIGMA DIAGNOSTICS, INC. PHENYTOIN FPIA REAGENT SET AND CALIBRATORS 10/27/1994
K842586 WINDSOR LABORATORIES, INC. PHENYTOIN KIT FLUORESCENCE POLARIZATION 09/26/1984


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