FDA 510(k) Applications Submitted by Tara Viviani
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN120008 |
01/06/2012 |
STRATIFY JCV(TM) ANTIBODY |
FOCUS DIAGNOSTICS, INC. |
| K100148 |
01/19/2010 |
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
FOCUS DIAGNOSTICS, INC. |
| K120413 |
02/10/2012 |
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK |
FOCUS DIAGNOSTICS, INC. |
| K160552 |
02/29/2016 |
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform |
EDWARDS LIFESCIENCES, LLC |
| K070626 |
03/06/2007 |
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
| K120986 |
04/02/2012 |
STRATIFY JCV DXSELECT |
FOCUS DIAGNOSTICS, INC. |
| K071002 |
04/09/2007 |
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT |
BECKMAN COULTER, INC. |
| K212147 |
07/09/2021 |
Simplexa COVID-19 Direct |
DiaSorin Molecular LLC |
| K102170 |
08/02/2010 |
SIMPLEXA FLU A/B & RSV |
FOCUS DIAGNOSTICS, INC. |
| K102314 |
08/16/2010 |
3M INTEGRATED CYCLER (110V) & (220V) |
FOCUS DIAGNOSTICS, INC. |
| K182479 |
09/10/2018 |
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus |
Hycor Biomedical |
| K071277 |
05/07/2007 |
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS |
BECKMAN COULTER, INC. |
| K071280 |
05/07/2007 |
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS |
BECKMAN COULTER, INC. |
| K071283 |
05/07/2007 |
SYNCHRON SYSTEMS CREATININE REAGENT |
BECKMAN COULTER, INC. |
|
|
