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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
DEN130049
11/25/2013
SIMPLEXA HSV 1&2 DIRECT
FOCUS DIAGNOSTICS
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