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FDA 510(k) Applications Submitted by RADHA GOOLABSINGH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K181599
06/18/2018
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
Beckman Coulter
K972287
06/19/1997
DADE TRU-LIQUID BILIRUBIN CONTROL
DADE INTL., INC.
K022800
08/23/2002
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
HYPERION, INC.
K013213
09/26/2001
HYPERION VISIQUANT ANA TEST KIT
HYPERION, INC.
K964862
12/04/1996
TROPONIN-I TEST SYSTEM
DADE INTL., INC.
K965213
12/30/1996
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
DADE INTL., INC.
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