ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
FDA 510(k) K153375 · Abbott Laboratories
510(k) numberK153375
Submission
- Device name
- ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- November 23, 2015
- Decision date
- August 12, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRG – System, Test, Vitamin D
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1825
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerMRG · Traditional | Shenzhen New Industries Biomedical Engineering… | 04/12/2024SE |
| K221817 | ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional | Immunostics Inc., | 09/22/2023SE |
| K223503 | Access 25(OH) Vitamin D TotalMRG · Traditional | Beckman Coulter, Inc. | 01/19/2023SE |
| K210901 | Elecsys Vitamin D total IIIMRG · Traditional | Roche Diagnostics | 09/01/2021SE |
| K200509 | ADVIA Centaur Vitamin D Total (VitD)MRG · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/29/2020SE |
| K191499 | MAGLUMI 2000 25-OH Vitamin DMRG · Traditional | Shenzhen New Industries Biomedical Engineering… | 08/01/2019SE |
| K180577 | BioPlex 2200 25-OH Vitamin D KitMRG · Traditional | Bio-Rad Laboratories | 06/22/2018SE |
| K172992 | Diazyme EZ Vitamin D AssayMRG · Traditional | Diazyme Laboratories | 01/11/2018SE |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CALMRG · Traditional | Siemens Healthcare Diagnostics | 03/16/2017SE |
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…MRG · Traditional | Roche Diagnostics | 02/08/2017SE |
More from Roche Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls cleared by the FDA?
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls (K153375) received a 510(k) decision of Substantially Equivalent on August 12, 2016, 263 days after the submission was received.
What is the product code of K153375?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.