FDA 510(k) Applications Submitted by Siemens Healthcare Diagnostics Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K121994 07/06/2012 DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR Siemens Healthcare Diagnostics Inc.
K170293 01/31/2017 Emit II Plus Cocaine Metabolite Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
K171771 06/14/2017 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay Siemens Healthcare Diagnostics Inc.
K172910 09/25/2017 Emit II Plus Oxycodone Assay Siemens Healthcare Diagnostics Inc.
K173909 12/22/2017 Dimension Hemoglobin A1c Assay Siemens Healthcare Diagnostics Inc.
K141999 07/23/2014 ADVIA CENTAUR TSH Siemens Healthcare Diagnostics Inc.
K122398 08/07/2012 RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS Siemens Healthcare Diagnostics Inc.
K172322 08/01/2017 Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics Inc.
K222104 07/18/2022 Atellica« CH Diazo Total Bilirubin (D_TBil) Siemens Healthcare Diagnostics Inc.
K223078 09/30/2022 Atellica« CH Diazo Direct Bilirubin (D_DBil) Siemens Healthcare Diagnostics Inc.
K141772 07/01/2014 IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K142811 09/29/2014 IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) Siemens Healthcare Diagnostics Inc.
K133128 09/30/2013 IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION Siemens Healthcare Diagnostics Inc.
K191454 05/31/2019 Atellica CH Amylase_2 (AMY_2) Siemens Healthcare Diagnostics Inc.
K172201 07/21/2017 Atellica IM Folate Assay Siemens Healthcare Diagnostics Inc.
K163658 12/23/2016 ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay Siemens Healthcare Diagnostics Inc.
K141444 06/02/2014 IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL Siemens Healthcare Diagnostics Inc.
K093987 12/24/2009 IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 Siemens Healthcare Diagnostics Inc.
K140818 04/01/2014 IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C Siemens Healthcare Diagnostics Inc.
K132801 09/13/2013 IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY Siemens Healthcare Diagnostics Inc.
K133816 12/16/2013 IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K140267 02/03/2014 ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) Siemens Healthcare Diagnostics Inc.
K140505 02/27/2014 ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL Siemens Healthcare Diagnostics Inc.
K181002 04/16/2018 Atellica IM BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics Inc.
K142723 09/23/2014 ADVIA Centaur Cortisol (COR) Assy Siemens Healthcare Diagnostics Inc.
K140842 04/02/2014 DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART Siemens Healthcare Diagnostics Inc.
K140859 04/03/2014 DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT Siemens Healthcare Diagnostics Inc.
K121084 04/10/2012 LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L Siemens Healthcare Diagnostics Inc.
K113373 11/16/2011 DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL Siemens Healthcare Diagnostics Inc.
K140541 03/04/2014 IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C Siemens Healthcare Diagnostics Inc.
K131536 05/29/2013 IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K131662 06/07/2013 IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K122534 08/20/2012 IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K112523 08/31/2011 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics Inc.
K133124 09/30/2013 IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA Siemens Healthcare Diagnostics Inc.
K081319 05/12/2008 DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 Siemens Healthcare Diagnostics Inc.
K081857 07/01/2008 DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 Siemens Healthcare Diagnostics Inc.
K081789 06/25/2008 DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR Siemens Healthcare Diagnostics Inc.
K221119 04/18/2022 RCRP Flex reagent cartridge Siemens Healthcare Diagnostics Inc.
K212223 07/16/2021 Atellica CH Enzymatic Creatinine_3 (ECre3) Siemens Healthcare Diagnostics Inc.
K193489 12/17/2019 ADVIA Centaur BR Siemens Healthcare Diagnostics Inc.
K193493 12/17/2019 ADVIA Centaur Total IgE (tIgE) Siemens Healthcare Diagnostics Inc.
K102779 09/24/2010 EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C Siemens Healthcare Diagnostics Inc.
K222116 07/18/2022 Atellica« CI Analyzer, Atellica« IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica« CH Albumin BCP (AlbP) Siemens Healthcare Diagnostics Inc.
K222438 08/12/2022 A-LYTE« Integrated Multisensor (IMT Na K Cl) Siemens Healthcare Diagnostics Inc.
K222439 08/12/2022 Atellica« CH Phencyclidine (Pcp), Atellica« CH Vancomycin (Vanc) Siemens Healthcare Diagnostics Inc.
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.
K171642 06/02/2017 Atellica IM Ferritin Assay Siemens Healthcare Diagnostics Inc.
K122599 08/27/2012 ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR Siemens Healthcare Diagnostics Inc.
K132638 08/23/2013 DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics Inc.
K133728 12/06/2013 DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics Inc.
K083339 11/12/2008 DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) Siemens Healthcare Diagnostics Inc.
K081716 06/18/2008 ADVIA CENTAUR HAVM ASSAY Siemens Healthcare Diagnostics Inc.
K132249 07/19/2013 ADVIA CENTAUR FT4, ADVIA CENTAUR T4 Siemens Healthcare Diagnostics Inc.
K102681 09/17/2010 ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) 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.
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.
K221801 06/21/2022 ADVIA Centaur« Anti-Mⁿllerian Hormone (AMH) Siemens Healthcare Diagnostics Inc.
K192790 09/30/2019 Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics Inc.
K110586 03/01/2011 ADVIA CENTAUR VITAMIN D TOTAL ASSAY Siemens Healthcare Diagnostics Inc.
K123046 09/28/2012 ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR Siemens Healthcare Diagnostics Inc.
K100375 02/12/2010 DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 Siemens Healthcare Diagnostics Inc.
K200509 03/02/2020 ADVIA Centaur Vitamin D Total (VitD) Siemens Healthcare Diagnostics Inc.
K191533 06/10/2019 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG Siemens Healthcare Diagnostics Inc.
K081294 05/07/2008 ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS Siemens Healthcare Diagnostics Inc.
K133156 10/17/2013 ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA Siemens Healthcare Diagnostics Inc.
K083373 11/14/2008 IMMULITE 2000 FREE T4 Siemens Healthcare Diagnostics Inc.
K133601 11/25/2013 ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY Siemens Healthcare Diagnostics Inc.
K081299 05/08/2008 DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA Siemens Healthcare Diagnostics Inc.
K090330 02/10/2009 DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 Siemens Healthcare Diagnostics Inc.
K103548 12/03/2010 ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 Siemens Healthcare Diagnostics Inc.
K143504 12/10/2014 IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material Siemens Healthcare Diagnostics Inc.
K111394 05/18/2011 MICROSCAN MICROSTEP Siemens Healthcare Diagnostics Inc.
K150039 01/09/2015 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) Siemens Healthcare Diagnostics Inc.
K121576 05/30/2012 IMMULITE 2000 ANTI-CCP IGG ASSAY Siemens Healthcare Diagnostics Inc.
K133122 09/30/2013 IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) Siemens Healthcare Diagnostics Inc.
K080578 03/03/2008 DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA Siemens Healthcare Diagnostics Inc.
K081074 04/16/2008 DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 Siemens Healthcare Diagnostics Inc.
K081103 04/18/2008 LOCI THYROID CALIBRATOR WITH MODEL RC610 Siemens Healthcare Diagnostics Inc.
K081992 07/14/2008 DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 Siemens Healthcare Diagnostics Inc.
K082030 07/17/2008 DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 Siemens Healthcare Diagnostics Inc.
K082638 09/10/2008 ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL Siemens Healthcare Diagnostics Inc.


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