FDA 510(k) Applications Submitted by MATTHEW GEE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150403 |
02/18/2015 |
ADVIA Centaur TSH3-Ultra |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K160647 |
03/07/2016 |
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 |
Siemens Healthcare Diagnostics Inc. |
| K171274 |
05/01/2017 |
ADVIA Centaur High-Sensitivity Troponin I (TNIH) |
Siemens Healthcare Diagnostics Inc. |
| K171566 |
05/30/2017 |
Atellica IM High-Sensitivity Troponin I (TNIH) |
Siemens Healthcare Diagnostics Inc. |
| K191578 |
06/14/2019 |
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control |
Siemens Healthcare Diagnostics Inc. |
| K151986 |
07/17/2015 |
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| K142826 |
09/30/2014 |
ADVIA Centaur Toxoplasma M (Toxo M) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K133491 |
11/13/2013 |
ADVIA CENTAUR TESTOSTERONE (TSTO) |
Siemens Healthcare Diagnostics Inc. |
| DEN190056 |
12/26/2019 |
ADVIA Centaur Enhanced Liver Fibrosis (ELF) |
Siemens Healthcare Diagnostics Inc. |
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