FDA 510(k) Applications for Medical Device:
Elisa, Antibody, West Nile Virus

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K153303 EUROIMMUN US, INC. 1100 THE AMERICAN ROAD
MORRIS PLAINS NJ 07950
K153308 EUROIMMUN US, INC. 1100 THE AMERICAN ROAD
MORRIS PLAINS NJ 07950
K031953 FOCUS TECHNOLOGIES, INC. 10703 PROGRESS WAY
CYPRESS CA 90630-4737
K040854 FOCUS TECHNOLOGIES, INC. 10703 PROGRESS WAY
CYPRESS CA 90630-4737
K031952 FOCUS TECHNOLOGIES, INC. 10703 PROGRESS WAY
CYPRESS CA 90630-4737
K041817 INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600
SEATTLE WA 98104
K041068 PANBIO LIMITED 116 LUTWYCHE RD.
WINDSOR, BRISBANE 4030
DEN030004 PANBIO LIMITED 116 LUTWYCHE RD.
WINDSOR, BRISBANE 4030
K041231 PANBIO LIMITED 116 LUTWYCHE RD.
WINDSOR, BRISBANE 4030
K052519 SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL
TORONTO, ONTARIO M9C 1C2




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