510(k) Report

Devices descending from K971640

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052549Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc.20052Class I
+2K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics20131Class I
+3K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics20150Class I