510(k) Report

Devices descending from K903628

4 later devices reach Aia-Pack Iri through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021535Advia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp.200232
+2K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics20160—
+2K060359Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd.20061—
+3K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics20170—