FDA 510(k) Applications Submitted by Cindy Morrow

FDA 510(k) Number Submission Date Device Name Applicant
K040026 01/07/2004 BD FACS 7-COLOR SETUP BEADS BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K980858 03/05/1998 MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K000897 03/21/2000 CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE BD Biosciences
K971110 03/26/1997 TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K180958 04/12/2018 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable Shockwave Medical, Inc.
K091596 06/02/2009 EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST EVALVE INC
K191840 07/09/2019 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) Shockwave Medical, Inc.
K062195 08/01/2006 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC.
K973483 09/15/1997 FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K072719 09/25/2007 CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC CORP.
K963963 10/02/1996 MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K974360 11/19/1997 MULTITEST CD3/CD8/CD45/CD4 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS


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