FDA 510(k) Applications for Medical Device Product Code "KHO"
(Fluorometer, For Clinical Use)

FDA 510(k) Number Applicant Device Name Decision Date
K973547 BIOSITE INCORPORATED TRIAGE STATMETER 01/13/1998
K962919 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC SYSTEM 10/18/1996
K112161 RADIOMETER MEDICAL APS AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. 01/20/2012
K971103 TOSOH MEDICS, INC. AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM 06/27/1997


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