FDA 510(k) Applications Submitted by Sharon Young
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190219 |
02/04/2019 |
Simplexa VZV Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
| K220963 |
04/01/2022 |
Simplexa COVID-19 & Flu A/B Direct |
DiaSorin Molecular LLC |
| 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 |
| K201505 |
06/05/2020 |
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack |
DiaSorin Molecular LLC |
| K142365 |
08/25/2014 |
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack |
FOCUS DIAGNOSTICS |
| K192376 |
08/30/2019 |
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
| K182467 |
09/10/2018 |
Simplexa GBS Direct, Simplexa GBS Positive Control Pack |
DiaSorin Molecular LLC |
| K202755 |
09/21/2020 |
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack |
DiaSorin Molecular LLC |
| K173498 |
11/13/2017 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
| K183223 |
11/20/2018 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
| K113433 |
11/21/2011 |
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT |
FOCUS DIAGNOSTICS, INC. |
| DEN130049 |
11/25/2013 |
SIMPLEXA HSV 1&2 DIRECT |
FOCUS DIAGNOSTICS |
| K173798 |
12/14/2017 |
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack |
DiaSorin Molecular LLC |
| K143651 |
12/23/2014 |
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack |
FOCUS DIAGNOSTICS, INC. |
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