Data / Medical devices / Hungary / Diamond Diagnostics Inc.
Diamond Diagnostics Inc.: FDA-registered device maker in Budapest, Hungary, 124 510(k) clearances
Diamond Diagnostics Inc. is registered with the FDA (registration 3006198300) in Budapest, Hungary. It lists 241 device types. The FDA files 124 510(k) clearances under its listings, the newest dated August 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006198300
- Address
- 6 Oradna Street, Budapest, Hungary, 1044
- Owner or operator
- Diamond Diagnostics Inc. (10028706)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- February 26, 2009
- Registered through
- 2026
- Brand names listed
- ANALYZER, CHEMISTRY, Analyzer, Assay System, Automated Test System, BK BUN, BK Creatinine, BK Glucose, BK ISE 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 124.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2023 | K220031 | Alinity h-series System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 13, 2023 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| June 7, 2023 | K212183 | STA R Max 3, STA Compact Max 3 | JPA | Substantially Equivalent | Diagnostica Stago S.A.S | accessdata.fda.gov |
| May 19, 2023 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 10, 2022 | K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | JLW | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 16, 2022 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | CFR | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| August 20, 2021 | K203790 | GEM Premier 5000 | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| April 16, 2020 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | GKZ | Substantially Equivalent | Beckman Coulter | accessdata.fda.gov |
| March 15, 2019 | K190294 | CELL-DYN Emerald 22 AL System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 30, 2018 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | JFY | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. | accessdata.fda.gov |
| August 15, 2018 | K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | OCC | Substantially Equivalent | Cepheid | accessdata.fda.gov |
| April 23, 2018 | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | LKM | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| October 23, 2017 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 22, 2017 | K163342 | i-STAT Hematocrit test with i-STAT Alinity System | JPI | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 16, 2016 | K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | JGS | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 3, 2016 | K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | GKP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| January 26, 2016 | K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| January 11, 2016 | K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | Substantially Equivalent | Siemens Healthcare Diagnostic Products GmbH | accessdata.fda.gov |
| December 13, 2015 | K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | GKP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| November 20, 2015 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 16, 2015 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit | OUY | Substantially Equivalent | Cepheid | accessdata.fda.gov |
| September 18, 2015 | K143720 | Dimension Vista MMB Assay | JHY | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| December 5, 2014 | K141681 | SYSMEX XN SERIES | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| May 5, 2014 | K140887 | COBAS CT/NG V2.0 TEST | LSL | Substantially Equivalent | Roche Molecular Systems, Inc. | accessdata.fda.gov |
| August 22, 2013 | K131126 | OPTI CCA-TS2 | CHL | Substantially Equivalent | Opti Medical Systems, Inc. | accessdata.fda.gov |
| April 23, 2013 | K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | CFR | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| March 22, 2013 | K130276 | DIMENSION EXL WITH LM SYSTEM | JJE | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 8, 2013 | K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | OOI | Substantially Equivalent | Life Technologies Corporation | accessdata.fda.gov |
| February 12, 2013 | K130090 | STA COMPACT MAX | JPA | Substantially Equivalent | Diagnostica Stago, Incorporated | accessdata.fda.gov |
| October 19, 2012 | K112605 | SYSMEX XN-SERIES | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| August 2, 2012 | K111534 | ABACUS 3CP | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
| March 27, 2012 | K112755 | ABACUS 5 | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
| March 23, 2012 | K110520 | BIOLIS 12I | CEM | Substantially Equivalent | Tokyo Boeki Medisys, Inc. | accessdata.fda.gov |
| December 23, 2011 | K112412 | AU5800(R) CHEMISTRY ANALYZER | CEM | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 22, 2011 | K110381 | CELL-DYN EMERALD 22 SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 1, 2011 | K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | CFR | Substantially Equivalent | Tokyo Boeki Medisys, Inc. | accessdata.fda.gov |
| June 28, 2011 | K110035 | INDIKO | JJE | Substantially Equivalent | Thermofisher Scientific OY | accessdata.fda.gov |
| March 24, 2011 | K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... | JGS | Substantially Equivalent | Elitechgroup Vital Scientific BV | accessdata.fda.gov |
| March 23, 2011 | K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | KQO | Substantially Equivalent | Iris International Inc., A Division of Iris Iris I | accessdata.fda.gov |
| February 8, 2011 | K103195 | I-STAT 1 WIRELESS ANALYZER | CGA | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| January 25, 2011 | K101741 | DIATRON PICTUS 400 | CGA | Substantially Equivalent | Diatron Group | accessdata.fda.gov |
| January 21, 2011 | K103529 | LIAISON XL ANALYZER MODEL 10050 | LOL | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| September 9, 2010 | K100853 | COBAS 8000 MODULAR SERIES ANALYZER | DCF | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| August 6, 2010 | K092686 | ABL90 FLEX SERIES | CEM | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| July 6, 2010 | K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG | OOI | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 28, 2010 | K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | OOI | Substantially Equivalent | Abbott Molecular, Inc. | accessdata.fda.gov |
| April 2, 2010 | K093555 | COBAS U411 TEST SYSTEM | KQO | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| March 30, 2010 | K091313 | SYSMEX MODEL XT-4000I | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| February 5, 2010 | K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | LKM | Substantially Equivalent | Iris International, Inc. | accessdata.fda.gov |
| December 22, 2009 | K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| October 20, 2009 | K090703 | POLY-CHEM 90 GLUCOSE | CFR | Substantially Equivalent | Polymedco, Inc. | accessdata.fda.gov |
| March 9, 2009 | K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | CIC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 4, 2009 | K081495 | CELL-DYN EMERALD SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 22, 2008 | K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM | JLW | Substantially Equivalent | Ortho-Clinical Diagnostics | accessdata.fda.gov |
| December 12, 2008 | K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| September 30, 2008 | K082562 | APPLIED BIOSYSTEMS 7500 FAST DX | NSU | Substantially Equivalent | Applied Biosystems, Inc. | accessdata.fda.gov |
| September 16, 2008 | K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | LCP | Substantially Equivalent | Tosoh Bioscience, Inc. | accessdata.fda.gov |
| July 31, 2008 | K080370 | ABL 80 CO-OX SYSTEM | CHL | Substantially Equivalent | Sendx Medical, Inc. | accessdata.fda.gov |
| February 1, 2008 | K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | CFR | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | accessdata.fda.gov |
| July 30, 2007 | K071211 | COBAS C 111 ANALYZER | CIT | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| May 25, 2007 | K070910 | SYSMEX MODEL UF1000I | LKM | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| September 29, 2006 | K061138 | ABX PENTRA 400 : CRP | DCK | Substantially Equivalent | Horiba Abx | accessdata.fda.gov |
| September 15, 2006 | K061974 | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| July 25, 2006 | K060540 | XPERT, GENEXPERT DX SYSTEM | NJR | Substantially Equivalent | Cepheid | accessdata.fda.gov |
| July 10, 2006 | K061667 | CELL-DYN RUBY SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 10, 2006 | K060656 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| March 31, 2006 | K052914 | RX IMOLA | CEM | Substantially Equivalent | Randox Laboratories, Ltd. | accessdata.fda.gov |
| March 13, 2006 | K060373 | COBAS 6000 SERIES SYSTEM | CEM | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| February 21, 2006 | K060162 | ACL ELITE; ACL ELITE PRO | JPA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 16, 2005 | K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) | CFR | Substantially Equivalent | Horiba Abx | accessdata.fda.gov |
| December 7, 2005 | K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | GKL | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| July 21, 2005 | K051215 | CELL-DYN SAPPHIRE SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| March 14, 2005 | K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| February 15, 2005 | K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | JJE | Substantially Equivalent | Tokyo Boeki Medical System , Ltd. | accessdata.fda.gov |
| October 8, 2004 | K041874 | ABL800 FLEX | CHL | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| July 2, 2004 | K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | CDD | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| February 11, 2004 | K032677 | SYSMEX POCH-100I | GKL | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| December 17, 2003 | K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | JJF | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| December 4, 2003 | K024014 | RANDOX RX DAYTONA | CGA | Substantially Equivalent | Randox Laboratories, Ltd. | accessdata.fda.gov |
| October 17, 2003 | K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER | CEM | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| September 8, 2003 | K032524 | ADVIA 60 HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| July 24, 2003 | K032013 | COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 3, 2003 | K024002 | PENTRA 80 | GKZ | Substantially Equivalent | Abx Diagnostics | accessdata.fda.gov |
| August 21, 2002 | K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | CEW | Substantially Equivalent | Diagnostic Products Corp. | accessdata.fda.gov |
| July 17, 2002 | K020616 | BAYER RAPIDPOINT 405 SYSTEM | GKR | Substantially Equivalent | Bayer Diagnostics Corp. | accessdata.fda.gov |
| May 14, 2002 | K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | JPD | Substantially Equivalent | Tosoh Medics, Inc. | accessdata.fda.gov |
| February 5, 2001 | K003796 | ADVIA 120 HEMATOLOGY | GKZ | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| October 26, 2000 | K002646 | ABX MICROS CRP | GKZ | Substantially Equivalent | Abx Diagnostics | accessdata.fda.gov |
| December 7, 1999 | K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | GKP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 24, 1999 | K992834 | GEM PREMIER 3000 | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| May 21, 1999 | K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM | JGS | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| August 14, 1998 | K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | Sysmex Corp. | accessdata.fda.gov |
| June 9, 1998 | K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | CKB | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 24, 1998 | K974784 | AVL OPTI CRITICAL CARE ANALYZER | CEM | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| February 12, 1998 | K974651 | ABBOTT AXSYM SYSTEM | JJE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 27, 1997 | K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | Substantially Equivalent | Tosoh Medics, Inc. | accessdata.fda.gov |
| April 8, 1997 | K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER | JJE | Substantially Equivalent | Dpc Cirrus | accessdata.fda.gov |
| October 18, 1996 | K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | KHO | Substantially Equivalent | Johnson & Johnson Clinical Diagnostics, Inc. | accessdata.fda.gov |
| August 21, 1996 | K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM | JQX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
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Updated August 4, 2023. 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.