FDA 510(k) Applications Submitted by SIEMENS HEALTHCARE DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K083463 11/24/2008 DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M SIEMENS HEALTHCARE DIAGNOSTICS
K093645 11/25/2009 EXL ANEM CAL, MODEL RC640 SIEMENS HEALTHCARE DIAGNOSTICS
K130698 03/14/2013 DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) SIEMENS HEALTHCARE DIAGNOSTICS
K101460 05/26/2010 LOCI 8 CALIBRATOR, MODEL KC 646 SIEMENS HEALTHCARE DIAGNOSTICS
K102510 08/27/2010 DIMENSIONS HB1C KIT, MODEL DF105A SIEMENS HEALTHCARE DIAGNOSTICS
K150168 01/26/2015 Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) SIEMENS HEALTHCARE DIAGNOSTICS
K082503 08/29/2008 DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL SIEMENS HEALTHCARE DIAGNOSTICS
K093631 11/24/2009 B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 SIEMENS HEALTHCARE DIAGNOSTICS
K133512 11/15/2013 LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) SIEMENS HEALTHCARE DIAGNOSTICS
K150132 01/21/2015 IMMULITE IGF Control Module, IMMULITE Gastrin Control Module Siemens Healthcare Diagnostics
K143639 12/22/2014 IMMULITE 2000 CEA Calibration Verification Material Siemens Healthcare Diagnostics
K083386 11/17/2008 ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) SIEMENS HEALTHCARE DIAGNOSTICS
K091361 05/08/2009 IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS
K090257 02/02/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K091123 04/17/2009 ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS SIEMENS HEALTHCARE DIAGNOSTICS
K091289 05/01/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K101572 06/04/2010 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K091867 06/23/2009 ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 SIEMENS HEALTHCARE DIAGNOSTICS
K092993 09/28/2009 ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS
K093107 10/01/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K102904 10/01/2010 ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS
K083314 11/10/2008 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K083853 12/24/2008 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K101425 05/20/2010 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES SIEMENS HEALTHCARE DIAGNOSTICS
K110061 01/10/2011 CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS
K090346 02/11/2009 ADVIA 2120/2120I BODY FLUIDS SIEMENS HEALTHCARE DIAGNOSTICS
K083844 12/24/2008 ADVIA CENTAUR TSH3-ULTRA METHOD SIEMENS HEALTHCARE DIAGNOSTICS
K093441 11/05/2009 DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 SIEMENS HEALTHCARE DIAGNOSTICS
K103683 12/17/2010 IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) SIEMENS HEALTHCARE DIAGNOSTICS
K071474 05/29/2007 DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 SIEMENS HEALTHCARE DIAGNOSTICS
K102644 09/14/2010 ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I SIEMENS HEALTHCARE DIAGNOSTICS
K162977 10/26/2016 ADVIA 2120i, ADVIA 2120 SIEMENS HEALTHCARE DIAGNOSTICS
K140790 03/31/2014 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) SIEMENS HEALTHCARE DIAGNOSTICS
K083445 11/21/2008 N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC SIEMENS HEALTHCARE DIAGNOSTICS
K083462 11/24/2008 DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 SIEMENS HEALTHCARE DIAGNOSTICS
K090236 02/02/2009 DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 SIEMENS HEALTHCARE DIAGNOSTICS
K083159 10/27/2008 BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 SIEMENS HEALTHCARE DIAGNOSTICS
K083175 10/28/2008 BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 SIEMENS HEALTHCARE DIAGNOSTICS
K161954 07/18/2016 Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) Siemens Healthcare Diagnostics
K092283 07/29/2009 DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG SIEMENS HEALTHCARE DIAGNOSTICS
K162298 08/16/2016 LOCI Total Vitamin D Total Assay, LOCI VITD CAL SIEMENS HEALTHCARE DIAGNOSTICS
K143720 12/29/2014 Dimension Vista MMB Assay Siemens Healthcare Diagnostics
K090594 03/05/2009 DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID SIEMENS HEALTHCARE DIAGNOSTICS
K081732 06/19/2008 INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS SIEMENS HEALTHCARE DIAGNOSTICS
K093626 11/24/2009 INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS
K110169 01/20/2011 DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H SIEMENS HEALTHCARE DIAGNOSTICS
K110303 02/01/2011 STRATUS CS ACUTE CARE D-DIMER SIEMENS HEALTHCARE DIAGNOSTICS
K091916 06/30/2009 INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS
K100200 01/25/2010 ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 SIEMENS HEALTHCARE DIAGNOSTICS
K090900 04/01/2009 ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 SIEMENS HEALTHCARE DIAGNOSTICS
K101854 07/01/2010 ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 SIEMENS HEALTHCARE DIAGNOSTICS
K093732 12/04/2009 ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 SIEMENS HEALTHCARE DIAGNOSTICS
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
K081013 04/09/2008 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN SIEMENS HEALTHCARE DIAGNOSTICS
K083262 11/05/2008 MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) SIEMENS HEALTHCARE DIAGNOSTICS
K112999 10/07/2011 DIMENSION CLINICAL CHEMISTRY SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS
K091216 04/27/2009 CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 SIEMENS HEALTHCARE DIAGNOSTICS
K151964 07/16/2015 Xprecia Stride Coagulation System, Xprecia System PT Controls SIEMENS HEALTHCARE DIAGNOSTICS
K081300 05/08/2008 DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS
K080167 01/23/2008 ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS SIEMENS HEALTHCARE DIAGNOSTICS
K121981 07/06/2012 ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY SIEMENS HEALTHCARE DIAGNOSTICS
K081769 06/23/2008 INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 SIEMENS HEALTHCARE DIAGNOSTICS
K100433 02/16/2010 IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, SIEMENS HEALTHCARE DIAGNOSTICS
K100321 02/04/2010 DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 SIEMENS HEALTHCARE DIAGNOSTICS
K100344 02/05/2010 DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 SIEMENS HEALTHCARE DIAGNOSTICS
K100778 03/19/2010 DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A SIEMENS HEALTHCARE DIAGNOSTICS
K121907 06/29/2012 DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS
K112142 07/26/2011 DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS
K122323 08/01/2012 DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI SIEMENS HEALTHCARE DIAGNOSTICS
K123321 10/26/2012 DIMENSION CHEMISTRY III CALIBRATORY SIEMENS HEALTHCARE DIAGNOSTICS
K123320 10/26/2012 DIMENSION AMMONIA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS
K123677 11/30/2012 DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) SIEMENS HEALTHCARE DIAGNOSTICS
K100289 02/02/2010 ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 SIEMENS HEALTHCARE DIAGNOSTICS
K110934 04/04/2011 ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY SIEMENS HEALTHCARE DIAGNOSTICS
K091264 04/30/2009 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 SIEMENS HEALTHCARE DIAGNOSTICS
K091949 07/01/2009 MICROSCAN MICROSTREP PLUS, MODEL B1027-201 SIEMENS HEALTHCARE DIAGNOSTICS
K092919 09/23/2009 MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 SIEMENS HEALTHCARE DIAGNOSTICS
K110277 01/31/2011 RAPIDPOINT 405 NEONATAL BILIRUBIN SIEMENS HEALTHCARE DIAGNOSTICS
K122539 08/21/2012 MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS
K113216 11/01/2011 RAPIDPOINT 500 BLOOD GAS ANALYER SIEMENS HEALTHCARE DIAGNOSTICS
K162538 09/12/2016 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator SIEMENS HEALTHCARE DIAGNOSTICS
K140717 03/20/2014 CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT SIEMENS HEALTHCARE DIAGNOSTICS
K081731 06/19/2008 DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 SIEMENS HEALTHCARE DIAGNOSTICS
K082645 09/11/2008 DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 SIEMENS HEALTHCARE DIAGNOSTICS
K082680 09/15/2008 LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 SIEMENS HEALTHCARE DIAGNOSTICS
K083465 11/24/2008 DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS
K083579 12/04/2008 DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 SIEMENS HEALTHCARE DIAGNOSTICS
K081643 06/12/2008 DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 SIEMENS HEALTHCARE DIAGNOSTICS
K081683 06/17/2008 LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 SIEMENS HEALTHCARE DIAGNOSTICS
K083487 11/25/2008 EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS


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