510(k) Report

Devices descending from K121237

1 later device reach Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG…Abbott Point of Care, Inc.20150—