IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
FDA 510(k) K161831 · Immunodiagnostic Systems , Ltd.
510(k) numberK161831
Submission
- Device name
- IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, GB - Received
- July 5, 2016
- Decision date
- November 15, 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
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|---|---|---|---|
| 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 |
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| K200475 | IDS-iSYS Ostase BAPCIN · Traditional | 09/30/2020SE |
| K190121 | Ids SHBGCDZ · Traditional | 06/17/2019SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | 01/31/2017SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | 05/17/2016SE |
| K142351 | 25-Hydroxy Vitamin Ds EIAMRG · Traditional | 08/25/2015SE |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | 04/21/2015SE |
Questions and answers
When was IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set cleared by the FDA?
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (K161831) received a 510(k) decision of Substantially Equivalent on November 15, 2016, 133 days after the submission was received.
What is the product code of K161831?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.