510(k) Report

Devices descending from K020217

12 later devices reach Acs:180 and Advia Centaur Ipth Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc.20134—
+1K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135—
+1K132391Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB…Siemens Helathcare Diagnostics, Inc.20130—
+2K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+2K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc.20143—
+2K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+2K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+3K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc.20181—
+3K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…DiaSorin, Inc.20180—
+3K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+3K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+4K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.202201