Data / Medical devices / Germany / Siemens Healthcare Diagnostics Products GmbH
Siemens Healthcare Diagnostics Products GmbH: FDA-registered device maker in MARBURG Hesse, Germany, 127 510(k) clearances
Siemens Healthcare Diagnostics Products GmbH is registered with the FDA (registration 9610806) in MARBURG Hesse, Germany. It lists 80 device types. The FDA files 127 510(k) clearances under its listings, the newest dated August 11, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9610806
- FEI number
- 3001644026
- Address
- 76 Emil-Von-Behring Strasse, MARBURG Hesse, Germany, 35041
- Owner or operator
- SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 26, 2001
- Registered through
- 2027
- Brand names listed
- ADVIA 2120 and ADVIA 2120i Aspiration pathway Wash Kit, ADVIA 2120 and ADVIA 2120i Perox Flow cell wash kit, ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash Kit, ADVIA 2120 and ADVIA 2120i Vent Line Wash Kit, ADVIA Chemistry, ADVIA Chemistry Cystatin C_2 Calibrator, ADVIA Chemistry HAPT, Advanced D-Dimer Control Plasma 1 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 127.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2026 | K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | DAP | Substantially Equivalent | Siemens Healthcare Diagnostic Products GmbH | accessdata.fda.gov |
| March 28, 2025 | K242952 | INNOVANCE Antithrombin | JBQ | Substantially Equivalent | Siemens Healthcare Diagnostic Products GmbH | accessdata.fda.gov |
| October 10, 2024 | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | QLU | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| January 18, 2024 | K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | NQD | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 13, 2023 | K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | CFN | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| November 27, 2023 | K232624 | CardioPhase® hsCRP | DCN | Substantially Equivalent | Siemens Healthcare Diagnostic Products GmbH | accessdata.fda.gov |
| June 2, 2023 | K220728 | vWF Ag | GGP | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| September 29, 2022 | DEN200067 | INNOVANCE VWF Ac | QTY | Unknown | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| March 2, 2022 | K212379 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| October 29, 2021 | K201496 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| May 3, 2019 | K190879 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| September 7, 2018 | K181525 | INNOVANCE Free PS Ag | GGP | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| November 17, 2017 | K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | DFH | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| August 22, 2017 | K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | KFF | Substantially Equivalent | Siemens Healthcare Diagnostics Prodcts GmbH | accessdata.fda.gov |
| May 12, 2017 | K171072 | N Latex Cystatin C; N Protein Standard UY | NDY | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| April 7, 2011 | K110169 | DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 29, 2010 | K093626 | INNOVANCE D-DIMER, MODEL OPBP09 | DAP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 21, 2009 | K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | DFZ | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| April 29, 2009 | K090594 | DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID | CFN | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| March 24, 2009 | K083445 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC | CFN | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| March 13, 2009 | K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | JZG | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| January 26, 2009 | K083175 | BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 | JPA | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| January 26, 2009 | K083159 | BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 | JPA | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| December 19, 2008 | K082503 | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL | DFH | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 24, 2008 | K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | DAP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| August 8, 2008 | K081299 | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA | DDG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 28, 2008 | K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | CFN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 21, 2008 | K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | DEB | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 21, 2007 | K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | DBA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 17, 2007 | K072435 | DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H | JIX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 19, 2007 | K072304 | FIBRINOGEN CALIBRATOR KIT | GFX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 8, 2007 | K071247 | N LATEX RF KIT | DHR | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 21, 2007 | K063663 | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H | DDG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 23, 2007 | K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | MSJ | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 15, 2007 | K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH | CHN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 15, 2007 | K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH | DGC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 23, 2007 | K063508 | DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN | JIX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 22, 2007 | K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | NDY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 11, 2007 | K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | DEM | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 28, 2006 | K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH | LPS | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 4, 2006 | K062035 | DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL | JIX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 22, 2006 | K061852 | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | CZW | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 19, 2006 | K061990 | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL | DCF | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 11, 2006 | K061802 | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH | NQD | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 6, 2006 | K061825 | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH | DCN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 25, 2006 | K060677 | N LATEX CDT | NAO | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 21, 2006 | K060489 | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | JOZ | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 29, 2006 | K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | LPS | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 28, 2006 | K053073 | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | DEB | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 28, 2006 | K053072 | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | DEM | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 16, 2006 | K053075 | N ANTISERA TO HUMAN TRANSFERRIN | DDG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 16, 2006 | K053074 | N ANTISERA TO HUMAN CERULOPLASMIN | DDB | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| June 29, 2005 | K050928 | DADE THROMBIN REAGENT | KQJ | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 2, 2005 | K050665 | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | CZW | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 15, 2005 | K042735 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) | CFN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 10, 2004 | K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | MIF | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 1, 2004 | K042333 | CONTROL PLASMA N, PROC CONTROL PLASMA | GGN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 21, 2004 | K042209 | CONTROL PLASMA N AND CONTROL PLASMA P | GGN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 16, 2004 | K041878 | N LATEX CYSTATIN | NDY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 27, 2004 | K041870 | N APOLIPOPROTEIN STANDARD SERUM | JIX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 7, 2003 | K032014 | N LATEX IGM | CFN | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 13, 2003 | K024038 | N LATEX IGA | CZP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 16, 2003 | K023141 | MODIFICATION TO STANDARD HUMAN PLASMA | JPA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 27, 2002 | K022290 | PROTEIN S AC | GGP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| June 10, 2002 | K021381 | MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 | JJY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 18, 2002 | K013128 | N LATEX LP(A) | DFC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 9, 2001 | K013126 | N LP(A) STANDARD SY | JIS | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 9, 2001 | K013114 | BCS SYSTEM | JPA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 18, 2001 | K013130 | N LP(A) CONTROL SY | JJX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 9, 2001 | K011665 | BCT SYSTEM | JPA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 15, 2001 | K003501 | N PROTEIN STANDARD UY CALIBRATOR | JIT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 20, 2001 | K003870 | THROMBOREL S | GJS | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 20, 2000 | K002731 | N LATEX B2-MICROGLOBULIN | JZG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 26, 2000 | K002541 | PROTEIN C REAGENT | GGP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 26, 2000 | K001647 | BN PROSPEC SYSTEM | JZW | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 16, 2000 | K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | GGC | Substantially Equivalent | Gradipore , Ltd. | accessdata.fda.gov |
| January 28, 2000 | K992957 | ADVANCED D-DIMER | DAP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 21, 1999 | K992456 | GRADILEIDEN V TEST | GGW | Substantially Equivalent | Gradipore , Ltd. | accessdata.fda.gov |
| November 30, 1999 | K993310 | APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH | JJY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 23, 1999 | K993273 | N LATEX FERRITIN | DBF | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 2, 1999 | K991157 | N LATEX STFR REAGENT | DDG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 28, 1999 | K984501 | DADE BEHRING BFTII | JPA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 7, 1999 | K991787 | N LATEX IGE MONO REAGENT | DGC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 22, 1998 | K974343 | DADE INNOVIN | GJS | Substantially Equivalent | Dade Intl., Inc. | accessdata.fda.gov |
| October 20, 1997 | K972929 | N ANTISERUM TO HUMAN ALBUMIN | DCF | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| July 25, 1997 | K972116 | VON WILLEBRAND REAGENT | GGP | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| May 19, 1997 | K970645 | BC THROMBIN REAGENT | GJA | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| May 5, 1997 | K970431 | BEHRING COAGULATION SYSTEM | JPA | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| January 15, 1997 | K964527 | N RHEUMATOLOGY STANDARD SL | JIX | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| August 1, 1996 | K960257 | N ANTISERUM TO C1 INHIBITOR | DBA | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| July 29, 1996 | K962407 | N/T PROTEIN CONTROL PY | GIL | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| July 16, 1996 | K962410 | N PROTEIN STANDARD PY | JIX | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| April 19, 1996 | K955450 | PATHROMTIN SL | GFO | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| October 3, 1994 | K943997 | BEHRING NEPHELOMETER II | DEW | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| April 19, 1994 | K934326 | MULTIFIBREN U | KQJ | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| April 19, 1994 | K933125 | BERICHROM ANTITHROMBIN III (A) | JPE | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| November 29, 1993 | K932787 | BATROXOBIN REAGENT | JCO | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| June 28, 1993 | K925200 | BERICHROM HEPARIN | KFF | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| June 8, 1993 | K924400 | CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA | GJT | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
| May 21, 1993 | K924396 | CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA | GJT | Substantially Equivalent | Behring Diagnostics, Inc. | accessdata.fda.gov |
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Updated August 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.