FDA 510(k) Applications Submitted by ANNA M LONGWELL

FDA 510(k) Number Submission Date Device Name Applicant
K120489 02/17/2012 TISSUE OF ORIGIN TEST KIT FFPE PATHWORK DIAGNOSTICS, INC.
K970836 02/24/1997 TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K971205 04/01/1997 TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K961623 04/26/1996 FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS BECTON DICKINSON MONOCLONAL CENTER
K062756 09/14/2006 PATHIAM IMAGING SOFTWARE FOR HER2/NEU BIOIMAGENE, INC.
K092967 09/25/2009 PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE PATHWORK DIAGNOSTICS
K946055 11/28/1994 TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K043580 12/28/2004 ALLIGATOR RETRIEVAL DEVICE (ARD) CHESTNUT MEDICAL TECHNOLOGIES, INC.
K970326 01/28/1997 TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K970742 02/28/1997 TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K965053 12/18/1996 TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K950342 01/27/1995 TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS


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