FDA 510(k) Applications for Medical Device Product Code "MRG"
(System, Test, Vitamin D)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K153375 | ABBOTT LABORATORIES | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | 08/12/2016 |
| K223503 | Beckman Coulter Inc | Access 25(OH) Vitamin D Total | 01/19/2023 |
| K142373 | BECKMAN COULTER, INC. | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | 12/22/2014 |
| K142362 | BECKMAN COULTER, INC. | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | 12/19/2014 |
| K180577 | Bio-Rad Laboratories | BioPlex 2200 25-OH Vitamin D Kit | 06/22/2018 |
| K141114 | Bio-Rad Laboratories | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | 01/09/2015 |
| K110619 | BIOKIT S.A. | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS | 11/23/2011 |
| K141463 | DiaSorin Inc. | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS | 12/10/2014 |
| K014030 | DIASORIN, INC. | 1,25-DIHYDROXYVITAMIN D125I RIA | 03/26/2002 |
| K032844 | DIASORIN, INC. | LIAISON 25 OH VITAMIN D | 02/12/2004 |
| K112725 | DIASORIN, INC. | LIAISON 25 OH VITAMIN D TOTAL ASSAY | 01/20/2012 |
| K071480 | DIASORIN, INC. | LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 | 10/01/2007 |
| K132492 | DIASORIN, INC. | LIAISON 25 TOTAL-D | 09/05/2013 |
| K123364 | DIASOURCE IMMUNOASSAYS, S.A. | 25OH VITAMIN D TOTAL ELISA TEST | 07/15/2013 |
| K102432 | DIAZYME LABORATORIES | DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, | 01/14/2011 |
| K122420 | DIAZYME LABORATORIES | DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA | 11/28/2012 |
| K133410 | DIAZYME LABORATORIES | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET | 03/14/2014 |
| K172992 | Diazyme Laboratories | Diazyme EZ Vitamin D Assay | 01/11/2018 |
| K072536 | ESA BIOSCIENCES INC. | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST | 05/07/2008 |
| K123660 | EUROIMMUN US | 25-OH VITAMIN D ELISA | 07/17/2013 |
| K153361 | FUJIREBIO DIAGNOSTICS, INC. | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | 04/15/2016 |
| K161831 | Immunodiagnostic Systems Ltd | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | 11/15/2016 |
| K051110 | IMMUNODIAGNOSTIC SYSTEMS LTD. | 1,25-DIHYDROXY VITAMIN D EIA | 07/06/2005 |
| K142351 | IMMUNODIAGNOSTIC SYSTEMS LTD. | 25-Hydroxy Vitamin Ds EIA | 08/25/2015 |
| K042519 | IMMUNODIAGNOSTIC SYSTEMS LTD. | GAMMA-B 1,25-DIHYDROXY VITAMIN D | 12/01/2004 |
| K991998 | IMMUNODIAGNOSTIC SYSTEMS LTD. | GAMMA-B 25-HYDROXY VITAMIN D RIA | 09/17/1999 |
| K123253 | IMMUNODIAGNOSTIC SYSTEMS LTD. | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D | 06/18/2013 |
| K140554 | IMMUNODIAGNOSTIC SYSTEMS LTD. | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | 12/19/2014 |
| K021163 | IMMUNODIAGNOSTIC SYSTEMS LTD. | OCTEIA 25-HYDROXY VITAMIN D | 05/10/2002 |
| K091849 | IMMUNODIAGNOSTIC SYSTEMS, INC. | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | 06/25/2010 |
| K221817 | Immunostics Inc. | ALFIS Vitamin D, ALFIS-3 Analyzer | 09/22/2023 |
| K953567 | INCSTAR CORP. | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | 09/25/1996 |
| K162754 | NanoEnTek USA, Inc. | FREND Vitamin D Test System | 01/12/2017 |
| K121608 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS | 02/15/2013 |
| K123983 | Qualigen, Inc. | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | 07/03/2013 |
| K113546 | Roche Diagnostics | ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 | 07/24/2012 |
| K162840 | Roche Diagnostics | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 | 02/08/2017 |
| K210901 | Roche Diagnostics | Elecsys Vitamin D total III | 09/01/2021 |
| K191499 | Shenzhen New Industries Biomedical Engineering Co., Ltd | MAGLUMI 2000 25-OH Vitamin D | 08/01/2019 |
| K162298 | SIEMENS HEALTHCARE DIAGNOSTICS | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | 03/16/2017 |
| K200509 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur Vitamin D Total (VitD) | 05/29/2020 |
| K133156 | Siemens Healthcare Diagnostics Inc. | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA | 07/24/2014 |
| K110586 | Siemens Healthcare Diagnostics Inc. | ADVIA CENTAUR VITAMIN D TOTAL ASSAY | 10/14/2011 |
| K123131 | Tosoh BioScience, Inc. | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI | 02/08/2013 |
| K150270 | TOSOH BIOSCIENCE, INC. | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | 10/26/2015 |
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