Diazyme EZ Vitamin D Assay
FDA 510(k) K172992 · Diazyme Laboratories
510(k) numberK172992
Submission
- Device name
- Diazyme EZ Vitamin D Assay
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- September 27, 2017
- Decision date
- January 11, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
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| K162754 | FREND Vitamin D Test SystemMRG · Traditional | Nanoentek USA, Inc. | 01/12/2017SE |
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Questions and answers
When was Diazyme EZ Vitamin D Assay cleared by the FDA?
Diazyme EZ Vitamin D Assay (K172992) received a 510(k) decision of Substantially Equivalent on January 11, 2018, 106 days after the submission was received.
What is the product code of K172992?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.