510(k) Report

Devices descending from K961573

4 later devices reach Tandem-R Ostase Immunoradiometric Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994278Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc.200016
+1K972666Tandem-MP Ostase Immunoenzymetric AssayHybritech, Inc.19971—
+2K232904Access OstaseBeckman Coulter20240—
+2K200475IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd.20200—