510(k) Report

Devices descending from K993210

5 later devices reach Access Hybritech Free Psa QC, Model 37219 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112603Access Hybritech P2PSA QC on the Access Immunoassay SystemsBeckman Coulter, Inc.20114—
+2K131536Immulite 2000 Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20131—
+2K122534Immulite 1000 Third Generation Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20131—
+3K133816Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+3K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—