Advia Centaur B-Type Natriuretic Peptide (BNP) Assay
FDA 510(k) K031038 · Bayer Healthcare, LLC
510(k) numberK031038
Submission
- Device name
- Advia Centaur B-Type Natriuretic Peptide (BNP) Assay
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- April 1, 2003
- Decision date
- June 23, 2003
- 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
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| 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 |
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| 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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Questions and answers
When was Advia Centaur B-Type Natriuretic Peptide (BNP) Assay cleared by the FDA?
Advia Centaur B-Type Natriuretic Peptide (BNP) Assay (K031038) received a 510(k) decision of Substantially Equivalent on June 23, 2003, 83 days after the submission was received.
What is the product code of K031038?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.