Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADVIA Centaur® NT-proBNPII (PBNPII)

K-Number: K220265 · 2023-09-24

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-09-24
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur® NT-proBNPII (PBNPII) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-09-24 under approval number K220265. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur® NT-proBNPII (PBNPII)?

ADVIA Centaur® NT-proBNPII (PBNPII) is a medical device that received FDA 510(k) clearance on 2023-09-24. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K220265.

When was ADVIA Centaur® NT-proBNPII (PBNPII) approved by the FDA?

ADVIA Centaur® NT-proBNPII (PBNPII) received FDA 510(k) clearance on 2023-09-24, under approval number K220265.

What company makes ADVIA Centaur® NT-proBNPII (PBNPII)?

ADVIA Centaur® NT-proBNPII (PBNPII) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur® NT-proBNPII (PBNPII)?

The FDA product code for ADVIA Centaur® NT-proBNPII (PBNPII) is NBC.

Other Devices by Siemens Healthcare Diagnostics, Inc.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161964ADVIA Centaur HAV IgM Assay K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

View all 71 devices →

Related Devices (Code: NBC)

K192380ST AIA-PACK BNPFujirebio Diagnostics,Inc. K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K232164Access NT-proBNPBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑