FDA 510(k) Applications Submitted by FOCUS DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K150962 04/10/2015 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack FOCUS DIAGNOSTICS
K141458 06/02/2014 SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK FOCUS DIAGNOSTICS
K142365 08/25/2014 Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack FOCUS DIAGNOSTICS
K133621 11/25/2013 SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS
DEN130049 11/25/2013 SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS


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