FDA 510(k) Applications for Medical Device:
Fluorescent Immunoassay Gentamicin

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K904226 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064 3500
K801084 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064 3500
K813539 AMERICAN DIAGNOSTIC CORP.
K972609 BIO-RAD 4000 ALFRED NOBEL DR.
HERCULES CA 94547-1803
K852158 BIOPROBE INTL., INC. 2842 WALNUT AVE., SUITE C
TUSTIN CA 92680
K894523 COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W.
WASHINGTON DC 20036
K801867 HOSPITAX
K841865 INNOTRON DIAGNOSTICS
K800032 INTL. DIAGNOSTIC TECHNOLOGY
K810942 MILES LABORATORIES, INC.
K955569 OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317
PORTLAND OR 97217-3935
K841162 PARAGON DIAGNOSTICS, INC.
K905721 PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE.
WESTWOOD MA 02090
K843827 ROCHE DIAGNOSTIC SYSTEMS, INC.
K945523 ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP
SOMERVILLE NJ 08876 3771
K943550 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST.LOUIS MO 63103
K820285 SYVA CO.
K782025 TECHNIA DIAGNOSTICS LTD.
K852013 WINDSOR LABORATORIES, INC. P.O. BOX 475487
GARLAND TX 75047




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