FDA 510(k) Applications for Medical Device:
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K062028 CELERA DIAGNOSTICS 1401 HARBOR BAY PKWY.
ALAMEDA CA 94502
K051435 CLINICAL MICRO SENSORS 757 SOUTH RAYMOND AVENUE
PASADENA CA 91105
K060543 CLINICAL MICRO SENSORS, INC. 757 SOUTH RAYMOND AVE.
PASADENA CA 91105
K083845 LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE.
TORONTO, ONTARIO M5G 1Y8
K163347 Luminex Molecular Diagnostics, Inc. 439 University Ave
Toronto M5g1y8
K083846 LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE.
TORONTO, ONTARIO M5G 1Y8
K163336 Luminex Molecular Diagnostics, Inc. 439 University Ave.
Toronto M5G 1Y8
K083294 NANOSPHERE, INC 4088 COMMERCIAL AVENUE
NORTHBROOK IL 60062
K090901 OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE.
PASADENA CA 91105
K063787 THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD.
MADISON WI 53719-1256
K060627 TM BIOSCIENCE CORPORATION 439 UNIVERSITY AVE.
TORONTO, ONTARIO M5G 1Y8
DEN050004 TM BIOSCIENCE CORPORATION 439 UNIVERSITY AVE., SUITE 900
TORONTO, ONTARIO M5G 1Y8




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