FDA 510(k) Applications for Medical Device:
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K935375 ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2
ABBOTT PARK IL 60064 3500
K953840 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064
K946328 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064
K844171 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K955873 CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST.
MEDFIELD MA 02052-1688
K841706 INNOTRON DIAGNOSTICS
K895827 INNOTRON OF OREGON, INC. 4432 SE 16TH AVE.
PORTLAND OR 97202
K872563 INNOTRON OF OREGON, INC. 4432 SE 16TH AVE.
PORTLAND OR 97202
K955562 OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317
PORTLAND OR 97217-3935
K896868 PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE.
WESTWOOD MA 02090
K843824 ROCHE DIAGNOSTIC SYSTEMS, INC.
NUTLEY NJ 07110
K936131 ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202
BRANCHBURG NJ 08876 1760
K862554 SCLAVO, INC. 1240 ELKO DR.
SUNNYVALE CA 94089
K943313 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST. LOUIS MO 63103
K842586 WINDSOR LABORATORIES, INC.




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