FDA 510(k) Applications Submitted by Kira Gordon
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100200 |
01/25/2010 |
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K120681 |
03/06/2012 |
ADVIA CHEMISTRY GLUH_3 REAGENTS |
Siemens Healthcare Diagnostics Inc. |
| K110736 |
03/16/2011 |
ADVIA CHEMISTRY FERRITIN (FRT) METHOD |
Siemens Healthcare Diagnostics Inc. |
| K090900 |
04/01/2009 |
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K131307 |
05/07/2013 |
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K181213 |
05/07/2018 |
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control |
Siemens Healthcare Diagnostics, Inc. |
| K171642 |
06/02/2017 |
Atellica IM Ferritin Assay |
Siemens Healthcare Diagnostics Inc. |
| K101854 |
07/01/2010 |
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K112343 |
08/15/2011 |
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K122599 |
08/27/2012 |
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
| K132664 |
08/27/2013 |
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K133067 |
09/27/2013 |
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K153365 |
11/20/2015 |
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K093732 |
12/04/2009 |
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K103701 |
12/20/2010 |
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K093939 |
12/22/2009 |
ADVIA CHEMISTRY SALICYLATE REAGENT |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K083906 |
12/30/2008 |
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 |
SIEMENS HEALTHCARE DIAGNOSTICS |
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