NBCClass II
Test, Natriuretic Peptide
21 CFR 862.1117 / Clinical Chemistry
NBC is the FDA product code for Test, Natriuretic Peptide, a class II device type, regulated under 21 CFR 862.1117. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 22 recalls.
Classification record
- Product code
- NBC
- Device name
- Test, Natriuretic Peptide
- Regulation
- 21 CFR 862.1117
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 46
- Ingested recalls
- 22
Clearances, product code NBC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 5 |
| 2005 | 5 |
| 2006 | 6 |
| 2007 | 2 |
| 2008 | 7 |
| 2010 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 3 |
Applicants with the most clearances
Product code NBC| Applicant | Clearances |
|---|---|
| Siemens Healthcare Diagnostics Inc. | 11 |
| Biosite Incorporated | 9 |
| Roche Diagnostics GmbH | 7 |
| Medrad, Inc. | 5 |
| Axis-Shield Diagnostics, Ltd. | 3 |
| Fujirebio Diagnostics, Inc. | 2 |
| Ortho-Clinical Diagnostics, Inc. | 2 |
| Beckman Coulter, Inc. | 1 |
| I-Stat Corp. | 1 |
| Mitsubishi Kagaku Iatron | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Abbott Point of Care Canada Limited
- ACRO BIOTECH Inc.
- Axis-Shield Diagnostics, Ltd.
- CTK Biotech, Inc.
- Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
- DIAMOND DIAGNOSTICS Inc
- Epitope Diagnostics, Inc.
- Fujirebio Diagnostics, Inc.
- Inpeco S.p.A.
- Nano-Ditech Corporation
- Nipro Corporation Odate Factory
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.