510(k) Report

Devices descending from K010266

8 later devices reach Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093758BGM Galectin -3Bg Medicine, Inc.20102—
+1K031038Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC200346
+2K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc.20201—
+2K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc.20140—
+2K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag201101
+2K043228Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC20050—
+2K040425Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC20041—
+3K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc.20210—