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
FDA 510(k) K123131 · Tosoh Bioscience, Inc.
510(k) numberK123131
Submission
- Device name
- 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
- Applicant
- Tosoh Bioscience, Inc.
South San Franciso, CA, US - Received
- October 4, 2012
- Decision date
- February 8, 2013
- 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 |
|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | 10/03/2025SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | 11/08/2021SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | 08/05/2021SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | 02/17/2016SE |
| K153417 | ST AIA-PACK PROG III Calibrator SetJIT · Traditional | 12/18/2015SE |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…MRG · Traditional | 10/26/2015SE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ · Traditional | 07/02/2015SE |
| K143296 | AIA-PACK C-Peptide Control SetJJX · Traditional | 12/16/2014SE |
| K143144 | ST AIA-PACK PROG II Calibrator SetJIT · Traditional | 12/03/2014SE |
| K140648 | ST Aia-Pack C-Peptide II Calibrator SetJIT · Abbreviated | 04/10/2014SE |
Questions and answers
When was 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 cleared by the FDA?
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 (K123131) received a 510(k) decision of Substantially Equivalent on February 8, 2013, 127 days after the submission was received.
What is the product code of K123131?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.