510(k) Report

Devices descending from K052549

2 later devices reach Leadcare II Blood Lead Testing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics20131Class I
+2K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics20150Class I