Abbott Laboratories - FDA 510(k) Cleared Devices
883
Total
868
Cleared
0
Denied
883 devices
Cleared
Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators,...
Chemistry
263d
Cleared
Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...
Microbiology
170d
Cleared
Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
Chemistry
136d
Cleared
Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
Chemistry
112d
Cleared
Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
Chemistry
30d
Cleared
Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
Chemistry
115d
Cleared
Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
Chemistry
95d
Cleared
May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
Chemistry
434d
Cleared
Apr 02, 2015
Total Bilirubin
Chemistry
34d
Cleared
Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Chemistry
392d
Cleared
Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
Chemistry
186d
Cleared
Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
Chemistry
210d
Cleared
Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
Chemistry
74d
Cleared
Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
Microbiology
263d
Cleared
Nov 27, 2012
ABBOTT ARCHITECT FREE T4
Chemistry
26d
Cleared
Sep 11, 2012
TESTOSTERONE TEST SYSTEM
Chemistry
252d
Cleared
Jun 28, 2012
ARCHITECT HAVAB-G
Microbiology
195d
Cleared
May 17, 2012
ARCHITECT B12
Chemistry
15d
Cleared
Apr 20, 2012
SAFETY SCREW CONNECTOR
Gastroenterology & Urology
123d
Cleared
Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
Chemistry
230d
Cleared
Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
Hematology
315d
Cleared
Oct 14, 2011
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
Toxicology
305d
Cleared
Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
Chemistry
219d
Cleared
Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
Chemistry
58d
Cleared
May 06, 2011
URIC ACID MODEL 3P39
Chemistry
241d
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