510(k) Report

Devices descending from K112603

4 later devices reach Access Hybritech P2PSA QC on the Access Immunoassay Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131536Immulite 2000 Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20131—
+1K122534Immulite 1000 Third Generation Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20131—
+2K133816Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+2K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—