MRG — System, Test, Vitamin D Class II
FDA product code MRG covers "System, Test, Vitamin D", a Class II medical device regulated under 21 CFR 862.1825. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MRG
- Device Class
- Class II
- Regulation Number
- 862.1825
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232587 | shenzhen new industries biomedical engineering co | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay ana | April 12, 2024 |
| K221817 | immunostics inc | ALFIS Vitamin D, ALFIS-3 Analyzer | September 22, 2023 |
| K223503 | beckman coulter | Access 25(OH) Vitamin D Total | January 19, 2023 |
| K210901 | roche diagnostics | Elecsys Vitamin D total III | September 1, 2021 |
| K200509 | siemens healthcare diagnostics | ADVIA Centaur Vitamin D Total (VitD) | May 29, 2020 |
| K191499 | shenzhen new industries biomedical engineering co | MAGLUMI 2000 25-OH Vitamin D | August 1, 2019 |
| K180577 | bio-rad laboratories | BioPlex 2200 25-OH Vitamin D Kit | June 22, 2018 |
| K172992 | diazyme laboratories | Diazyme EZ Vitamin D Assay | January 11, 2018 |
| K162298 | siemens healthcare diagnostics | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | March 16, 2017 |
| K162840 | roche diagnostics | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D to | February 8, 2017 |
| K162754 | nanoentek usa | FREND Vitamin D Test System | January 12, 2017 |
| K161831 | immunodiagnostic systems | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | November 15, 2016 |
| K153375 | abbott laboratories | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCH | August 12, 2016 |
| K153361 | fujirebio diagnostics | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | April 15, 2016 |
| K150270 | tosoh bioscience | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PAC | October 26, 2015 |
| K142351 | immunodiagnostic systems | 25-Hydroxy Vitamin Ds EIA | August 25, 2015 |
| K141114 | bio-rad laboratories | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR | January 9, 2015 |
| K142373 | beckman coulter | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25( | December 22, 2014 |
| K142362 | beckman coulter | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25( | December 19, 2014 |
| K140554 | immunodiagnostic systems | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | December 19, 2014 |