510(k) Report

Devices descending from K951848

3 later devices reach Aia-Pack CPR Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140648ST Aia-Pack C-Peptide II Calibrator SetTosoh Bioscience, Inc.20140—
+1K021532Advia Centaur and Acs:180 C-Peptide CalibratorBayer Diagnostics Corp.20021—
+2K082141Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10Biokit, S.A.20080—