Abbott Molecular, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Alinity m HCV, Alinity m EBV (09N43-095), Alinity m CMV
17
Total
16
Cleared
1
Denied
FDA 510(k) Regulatory Record - Abbott Molecular, Inc. Pathology ✕
4 devices
Cleared
Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
Pathology
112d
Not Cleared
Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
Pathology
111d
Cleared
Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721,...
Pathology
789d
Cleared
Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN)...
Pathology
582d