510(k) Report

Devices descending from K972231

2 later devices reach Osom Mono Test 143 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…SEKISUI Diagnostics, LLC20180—
+1K030215Biorapid MononucleosisInstrumentation Laboratory CO20030—