510(k) Report

Devices descending from K042884

7 later devices reach Dakocytomation ER/PR Pharmdx Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130861Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)Dako North America, Inc.20132—
+1K120663Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc.20132—
+1K081286Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634Dako North America, Inc.20091—
+2K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S20170—
+2K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use…Dako Denmark A/S20170—
+2K160922FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)…Dako North America, Inc.20160—
+2K110215Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.20120Class I