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FDA 510(k) Applications Submitted by JUDI WALLACH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K090358
02/12/2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
ABBOTT LABORATORIES INC
K230994
04/07/2023
Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
K191595
06/17/2019
ARCHITECT STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
K202525
09/01/2020
Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
K102699
09/20/2010
ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
ABBOTT LABORATORIES
K113704
12/16/2011
ARCHITECT HAVAB-G
ABBOTT LABORATORIES
K130255
02/01/2013
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
ABBOTT LABORATORIES
K140654
03/14/2014
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
ABBOTT LABORATORIES
K103627
12/13/2010
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
ABBOTT LABORATORIES
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