Abbott Molecular, Inc

FDA Filings

This page includes the latest FDA filings for Abbott Molecular, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
ABBOTT MOLECULAR, INC.
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG2014-05-09
ABBOTT MOLECULAR, INC.
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K15012010-05-28

Latest Premarket Applications

PMAManufacturerDevice NameDate
Abbott Molecular, Inc.
Abbott RealTime IDH1 Assay2019-11-12
Abbott Molecular, Inc.
RealTime IDH12019-09-24
Abbott Molecular Inc.
RealTime IDH22019-09-24
ABBOTT MOLECULAR
UroVysion Bladder Cancer Kit2019-08-26
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit2019-08-26
ABBOTT MOLECULAR, INC.
RealTime HBV2019-05-15
ABBOTT MOLECULAR, INC.
RealTime HCV2019-05-15
ABBOTT MOLECULAR
Abbott RealTime CMV2019-05-15
ABBOTT MOLECULAR
Abbott RealTime HCV GT II2019-05-15
ABBOTT MOLECULAR, INC.
PathVysion HER-2 DA Probe Kit2019-05-08
ABBOTT MOLECULAR
UroVysion Bladder Cancer Kit2019-05-08
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit2019-05-08
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit2019-05-08
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit2018-08-29
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit2018-08-29
ABBOTT MOLECULAR, INC.
PathVysion HER-2 DNA Probe Kit2018-08-29
ABBOTT MOLECULAR
UroVysion Bladder Cancer Kit2018-08-29
Abbott Molecular, Inc.
Abbott RealTime IDH12018-07-20
ABBOTT MOLECULAR
UroVysion Bladder Cancer Kit2018-07-11
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit2018-07-11
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit2018-07-11
ABBOTT MOLECULAR, INC.
Path Vysion HER-2 DNA Probe Kit2018-07-11
ABBOTT MOLECULAR, INC.
Abbott RealTime HCV Assay2018-06-21
ABBOTT MOLECULAR
Abbott RealTime HCV Genotype II Assay2018-06-21
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit2018-03-12
ABBOTT MOLECULAR, INC.
Path Vysion HER-2 DNA Probe Kit2018-03-12
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart Fish Probe Kit2018-03-12
ABBOTT MOLECULAR
UroVysion Bladder Cancer Kit2018-03-12
ABBOTT MOLECULAR
UroVysion Bladder Cancer Kit2017-12-06
ABBOTT MOLECULAR, INC.
Vysis CLL Fish Probe Kit2017-12-06

Latest De Novo Filings

De NovoManufacturerDevice NameDate
ABBOTT MOLECULAR, INC.
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)2013-07-29

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
RealTime
ABBOTT MOLECULAR INC.2019-11-26
RealTime
ABBOTT MOLECULAR INC.2019-11-26
RealTime
ABBOTT MOLECULAR INC.2019-11-26
RealTime
ABBOTT MOLECULAR INC.2019-11-26
RealTime
ABBOTT MOLECULAR INC.2019-11-21
Multi-Collect
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
UroVysion
ABBOTT MOLECULAR INC.2019-11-08
UroVysion
ABBOTT MOLECULAR INC.2019-11-08
UroVysion
ABBOTT MOLECULAR INC.2019-11-08
PathVysion
ABBOTT MOLECULAR INC.2019-11-08
PathVysion
ABBOTT MOLECULAR INC.2019-11-08
PathVysion
ABBOTT MOLECULAR INC.2019-11-08
PathVysion
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
RealTime
ABBOTT MOLECULAR INC.2019-11-08
Vysis
ABBOTT MOLECULAR INC.2019-11-08
Vysis
ABBOTT MOLECULAR INC.2019-11-08
Vysis
ABBOTT MOLECULAR INC.2019-11-08
VP2000
ABBOTT MOLECULAR INC.2019-11-08
Multi-Collect
ABBOTT MOLECULAR INC.2019-11-08
Vysis
ABBOTT MOLECULAR INC.2019-10-29
Vysis
ABBOTT MOLECULAR INC.2019-10-29
Vysis
ABBOTT MOLECULAR INC.2019-10-23
Vysis
ABBOTT MOLECULAR INC.2019-10-23
Vysis
ABBOTT MOLECULAR INC.2019-10-23
Vysis
ABBOTT MOLECULAR INC.2019-10-23
Vysis
ABBOTT MOLECULAR INC.2019-10-23
VP2000
ABBOTT MOLECULAR INC.2019-10-23

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