510(k) K252280
- Device
- Elecsys Anti-SARS-CoV-2 S
- Applicant
- Roche Diagnostics
- 510(k) number
- K252280
- Product code
- QVP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-13
- Date received
- 2025-07-22
- Regulation
- 866.3983
- Classification name
- Sars-Cov-2 Serology Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Amy Pierce
- Address
- 9115 Hague Rd. Indianapolis IN US 46256 46256
FDA Registration Numbers#
- 3012963943
- 2250051
- 3007111389
- 9610126
- 1319681
- 3002642396
- 3000308930
- 2032839
Source Documents#
Other 510(k) Records For Product Code QVP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-12-17 |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-06-10 |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |