NBC — Test, Natriuretic Peptide Class II
FDA product code NBC covers "Test, Natriuretic Peptide", a Class II medical device regulated under 21 CFR 862.1117. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NBC
- Device Class
- Class II
- Regulation Number
- 862.1117
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252169 | beckman coulter | Access BNP II | March 24, 2026 |
| K253539 | axis-shield diagnostics | Alere NT-proBNP for Alinity i | February 18, 2026 |
| K241176 | axis-shield diagnostics | Alere NT-proBNP for Alinity i Reagent Kit | January 16, 2025 |
| K232164 | beckman coulter | Access NT-proBNP | April 12, 2024 |
| K220265 | siemens healthcare diagnostics | ADVIA Centaur® NT-proBNPII (PBNPII) | September 24, 2023 |
| K223637 | roche diagnostics | Elecsys proBNP II, Elecsys proBNP II STAT | July 21, 2023 |
| K210546 | roche diagnostics | Elecsys proBNP II, Elecsys proBNP II STAT | March 31, 2022 |
| K211199 | tosoh bioscience | ST AIA-PACK BNP Assay | November 8, 2021 |
| K201312 | ortho clinical diagnostics | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | October 4, 2021 |
| K192380 | fujirebio diagnostics | ST AIA-PACK BNP | August 24, 2020 |
| K092649 | roche diagnostics | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109 | February 4, 2010 |
| K082645 | siemens healthcare diagnostics | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRI | September 22, 2008 |
| K063662 | response biomedical | RAMP NT-PROBNP ASSAY | July 21, 2008 |
| K080269 | biosite incorporated | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | June 6, 2008 |
| K080578 | siemens healthcare diagnostics | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CAR | May 16, 2008 |
| K073091 | biomerieux | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | February 29, 2008 |
| K072189 | mitsubishi kagaku iatron | PATHFAST NTPROBNP AND D-DIMER TESTS | February 5, 2008 |
| K072437 | roche diagnostics | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | February 5, 2008 |
| K071834 | dade behring | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | August 17, 2007 |
| K071767 | dade behring | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | August 4, 2007 |