FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
K Number: K052819
·
Decision Dec 23, 2005
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
29
Applicant Total
106
Review Days
80
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Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
- K Number
- K052819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- October 4, 2005
- Decision Date
- December 23, 2005
- Product Code
- DEM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEM), ordered by most recent decision date.
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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 |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | 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 |