FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
VITROS AFP
K Number: K213626
·
Decision Jun 15, 2022
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
16
Review Days
210
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Basic Information
- Device Name
- VITROS AFP
- K Number
- K213626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Clinical Diagnostics
- Date Received
- November 17, 2021
- Decision Date
- June 15, 2022
- Product Code
- LOJ
- 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 |
|---|---|---|---|
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | FDA class 2 | Immunology |
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Other Clearances by Ortho Clinical Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Aug 28, 2024 | Substantially Equivalent |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | May 8, 2024 | Substantially Equivalent |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Sep 5, 2023 | Substantially Equivalent |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Aug 23, 2023 | Substantially Equivalent |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Aug 9, 2023 | Substantially Equivalent |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Dec 12, 2022 | Substantially Equivalent |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Jan 28, 2022 | Substantially Equivalent |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Oct 4, 2021 | Substantially Equivalent |
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | Feb 25, 2020 | Substantially Equivalent |
| K163433 | VITROS Chemistry Products GLU Slides | Sep 18, 2017 | Substantially Equivalent |