510(k) Report

Devices descending from K860137

2 later devices reach Enzymun-Test Ferritin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964282Tina-Quant Ferritin AssayBoehringer Mannheim Corp.19971—
+2K100538Tina-Quant Ferritin Gen. 4Roche Diagnostics20100—