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FDA 510(k) Applications for Medical Device Product Code "PGH"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN130049
FOCUS DIAGNOSTICS
SIMPLEXA HSV 1&2 DIRECT
03/21/2014
K141458
FOCUS DIAGNOSTICS
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
07/01/2014
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