510(k) Report

Devices descending from K983424

5 later devices reach Abbott Archeitect Total B-HCG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories201713
+1K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG…Abbott Point of Care, Inc.20150—
+1K063720Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range VerifiersOrtho-Clinical Diagnostics200711
+2K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics20240—
+2K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…Abbott Laboratories20230—