FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K Number: K201312
·
Decision Oct 4, 2021
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
44
Applicant Total
16
Review Days
504
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
- VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
- K Number
- K201312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Clinical Diagnostics
- Date Received
- May 18, 2020
- Decision Date
- October 4, 2021
- Product Code
- NBC
- 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 |
|---|---|---|---|
| NBC | Test, Natriuretic Peptide | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NBC), ordered by most recent decision date.
Access BNP II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alere NT-proBNP for Alinity i
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alere NT-proBNP for Alinity i Reagent Kit
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access NT-proBNP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur® NT-proBNPII (PBNPII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys proBNP II, Elecsys proBNP II STAT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K213626 | VITROS AFP | Jun 15, 2022 | Substantially Equivalent |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Jan 28, 2022 | 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 |