Abbott Laboratories - FDA 510(k) Cleared Devices
883
Total
868
Cleared
0
Denied
883 devices
Cleared
Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
Chemistry
53d
Cleared
Feb 12, 1998
ABBOTT AXSYM SYSTEM
Chemistry
66d
Cleared
Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
Chemistry
25d
Cleared
Nov 10, 1997
IMX CA 15-3
Immunology
371d
Cleared
Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
Gastroenterology & Urology
494d
Cleared
Nov 04, 1997
AXSYM CA 125
Immunology
393d
Cleared
Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
Hematology
84d
Cleared
Sep 15, 1997
AXSYM CA 15-3
Immunology
350d
Cleared
Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
Hematology
137d
Cleared
Jun 24, 1997
ABBOTT AXSYM FOLATE
Chemistry
8d
Cleared
Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
Microbiology
579d
Cleared
Mar 24, 1997
AXSYM B12
Chemistry
90d
Cleared
Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
Cardiovascular
308d
Cleared
Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
Chemistry
20d
Cleared
Feb 26, 1997
LIFESHIELD BLUNT CANNULA
General Hospital
184d
Cleared
Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
Chemistry
62d
Cleared
Feb 10, 1997
CVP POLYURETHANE CATHETER
General Hospital
294d
Cleared
Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
Chemistry
15d
Cleared
Oct 30, 1996
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
Chemistry
36d
Cleared
Oct 30, 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
Chemistry
36d
Cleared
Oct 08, 1996
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
Hematology
313d
Cleared
Oct 02, 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
Gastroenterology & Urology
51d
Cleared
Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
Microbiology
392d
Cleared
Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
Microbiology
396d
Cleared
Sep 17, 1996
RV PACING LEAD
Cardiovascular
84d
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