FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
K Number: DEN210038
·
Decision May 5, 2023
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
4
Applicant Total
106
Review Days
592
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Basic Information
- Device Name
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
- K Number
- DEN210038
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3983
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- September 20, 2021
- Decision Date
- May 5, 2023
- Product Code
- QVP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| QVP | Sars-Cov-2 Serology Test | FDA class 2 | Microbiology |
Similar 510(k) Clearances
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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
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Other Clearances by Ortho-Clinical Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Oct 29, 2025 | Substantially Equivalent |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | May 5, 2023 | Unknown |
| K210858 | VITROS Chemistry Products PHBR Slides | Aug 13, 2021 | Substantially Equivalent |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Jun 7, 2019 | Substantially Equivalent |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Apr 26, 2019 | Substantially Equivalent |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Apr 3, 2019 | Substantially Equivalent |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Mar 27, 2019 | Substantially Equivalent |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Mar 14, 2019 | Substantially Equivalent |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Oct 30, 2018 | Substantially Equivalent |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | Oct 30, 2018 | Substantially Equivalent |