FDA 510(k) Applications Submitted by Gloria Lee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K081483 |
05/28/2008 |
XTAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K091667 |
06/09/2009 |
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| DEN190035 |
08/02/2019 |
Helix Laboratory Platform |
Helix OpCo, LLC |
| K192073 |
08/02/2019 |
Helix Genetic Health Risk App for late-onset AlzheimerÆs disease |
Helix OpCo, LLC |
| K093420 |
11/03/2009 |
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| DEN070013 |
12/04/2007 |
ID-TAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K083845 |
12/24/2008 |
XTAG CF60 KIT V2 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K083846 |
12/24/2008 |
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
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