FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
K Number: K113546
·
Decision Jul 24, 2012
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
183
Review Days
236
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
- K Number
- K113546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- December 1, 2011
- Decision Date
- July 24, 2012
- Product Code
- MRG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRG | System, Test, Vitamin D | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRG), ordered by most recent decision date.
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALFIS Vitamin D, ALFIS-3 Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access 25(OH) Vitamin D Total
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys Vitamin D total III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Vitamin D Total (VitD)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGLUMI 2000 25-OH Vitamin D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Roche Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | Jun 12, 2026 | Substantially Equivalent |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Apr 13, 2026 | Substantially Equivalent |
| K260048 | Elecsys Anti-HAV IgM | Apr 7, 2026 | Substantially Equivalent |
| K260049 | Elecsys Anti-HBc IgM | Apr 7, 2026 | Substantially Equivalent |
| K260046 | Elecsys Anti-HBc II | Apr 7, 2026 | Substantially Equivalent |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Apr 2, 2026 | Substantially Equivalent |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253839 | Elecsys Anti-SARS-CoV-2 | Dec 17, 2025 | Substantially Equivalent |
| K253188 | CoaguChek XS Plus System | Oct 24, 2025 | Substantially Equivalent |