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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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