Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
FDA 510(k) K162840 · Roche Diagnostics
510(k) numberK162840
Submission
- Device name
- Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- October 11, 2016
- Decision date
- February 8, 2017
- 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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|---|---|---|---|
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| 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 |
| K162754 | FREND Vitamin D Test SystemMRG · Traditional | Nanoentek USA, Inc. | 01/12/2017SE |
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Questions and answers
When was Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 cleared by the FDA?
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (K162840) received a 510(k) decision of Substantially Equivalent on February 8, 2017, 120 days after the submission was received.
What is the product code of K162840?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.