Triage B-Type Natriuretic Peptide (BNP) Test
FDA 510(k) K021317 · Biosite Incorporated
510(k) numberK021317
Submission
- Device name
- Triage B-Type Natriuretic Peptide (BNP) Test
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- April 25, 2002
- Decision date
- July 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBC – Test, Natriuretic Peptide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NBC
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|---|---|---|---|
| K252169 | Access BNP IINBC · Traditional | Beckman Coulter, Inc. | 03/24/2026SE |
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 01/16/2025SE |
| K232164 | Access NT-proBNPNBC · Traditional | Beckman Coulter, Inc. | 04/12/2024SE |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII)NBC · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/24/2023SE |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STATNBC · Traditional | Roche Diagnostics | 07/21/2023SE |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STATNBC · Traditional | Roche Diagnostics | 03/31/2022SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | Tosoh Bioscience, Inc. | 11/08/2021SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | Ortho Clinical Diagnostics | 10/04/2021SE |
| K192380 | ST Aia-Pack BNPNBC · Traditional | Fujirebio Diagnostics,Inc. | 08/24/2020SE |
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| K062840 | Triage Protein C Controls and Calibration Verification ControlsGGN · Traditional | 03/01/2007SE |
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Questions and answers
When was Triage B-Type Natriuretic Peptide (BNP) Test cleared by the FDA?
Triage B-Type Natriuretic Peptide (BNP) Test (K021317) received a 510(k) decision of Substantially Equivalent on July 1, 2002, 67 days after the submission was received.
What is the product code of K021317?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.