510(k) Report

Devices descending from K031038

4 later devices reach Advia Centaur B-Type Natriuretic Peptide (BNP) Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc.20201—
+1K043228Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC20050—
+1K040425Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC20041—
+2K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc.20210—