FDA 510(k) Applications Submitted by Gabriella Lakos
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150155 |
01/23/2015 |
NOVA Lite DAPI ANA Kit |
INOVA DIAGNOSTICS, INC. |
| K090760 |
03/23/2009 |
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 |
THERATEST LABORATORIES, INC. |
| K161258 |
05/04/2016 |
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit |
INOVA DIAGNOSTICS, INC. |
| K141210 |
05/09/2014 |
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS |
INOVA DIAGNOSTICS, INC. |
| K141328 |
05/21/2014 |
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS |
INOVA DIAGNOSTICS, INC. |
| K151429 |
05/28/2015 |
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols |
INOVA DIAGNOSTICS, INC. |
| K152013 |
07/21/2015 |
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls |
INOVA DIAGNOSTICS, INC. |
| K152635 |
09/15/2015 |
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls |
INOVA DIAGNOSTICS, INC. |
| K152875 |
09/30/2015 |
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls |
INOVA DIAGNOSTICS, INC. |
| K153150 |
11/02/2015 |
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 |
Inova Diagnostics, Inc. |
| K123593 |
11/21/2012 |
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, |
INOVA DIAGNOSTICS, INC. |
| DEN140039 |
12/15/2014 |
NOVA View Automated Fluorescense Microscope |
INOVA DIAGNOSTICS, INC. |
| K113863 |
12/30/2011 |
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS |
INOVA DIAGNOSTICS, INC. |
| K143754 |
12/31/2014 |
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 |
INOVA DIAGNOSTICS, INC. |
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