510(k) Report

Devices descending from K890051

1 later device reach Biotrack Aptt Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983892Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for…Roche Diagnostics/Boehringer Mannheim GmbH199901