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FDA 510(k) Applications Submitted by ANNA LONGWELL, ESQ.
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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