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    FDA 510(k), K121456, AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

    FDA 510(k), K121456, AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

    $1,570.37 USD
    $1,570.37 USD
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    510(K) Number: K121456
    Device Name: AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
    Manufacturer: ARKRAY, INC.
    Device Classification Name: automated urinalysis system
    Regulation Number: 862.2900
    Classification Product Code: KQO
    Date Received: 05/16/2012
    Decision Date: 02/01/2013
    Regulation Medical Specialty: Clinical Chemistry

    870 pages (1,075 of 1,945 original pages are fully redacted)
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