510(k) Report

Devices descending from K903025

1 later device reach Roche Isomune- CK through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981495Immulite CK-MB, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)Diagnostic Products Corp.19980—