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Abbott Molecular, Inc.

188 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Alinity m HR HPV (P230003/S009)Abbott Molecular, Inc.2025-10-17
Alinity m HBV (P200013/S027)Abbott Molecular, Inc.2025-10-17
Alinity m HR HPV (P230003/S008)Abbott Molecular, Inc.2025-09-24
Alinity m HBV (P200013/S026)Abbott Molecular, Inc.2025-09-24
Alinity m HR HPV (P230003/S006)Abbott Molecular, Inc.2025-09-10
Vysis CLL Fish Probe Kit (P150041/S007)Abbott Molecular, Inc.2025-08-08
Vysis ALK Break Apart FISH Probe Kit (P110012/S022)Abbott Molecular, Inc.2025-08-05
Alinity m HR HPV (P230003/S007)Abbott Molecular, Inc.2025-04-18
Abbott RealTime HBV (P080026/S026)Abbott Molecular, Inc.2025-04-18
Alinity m HBV (P200013/S025)Abbott Molecular, Inc.2025-04-18
Alinity m HBV Assay (P200013/S024)Abbott Molecular, Inc.2025-04-11
Abbott RealTime HBV Assay (P080026/S025)Abbott Molecular, Inc.2025-04-11
Alinity m HBV (P200013/S023)Abbott Molecular, Inc.2024-12-23
Alinity m HBV Assay (P200013/S021)Abbott Molecular, Inc.2024-09-13
Alinity m HR HPV Assay (P230003/S004)Abbott Molecular, Inc.2024-09-13
Alinity m CMV Assay (P210022/S012)Abbott Molecular, Inc.2024-09-13
Alinity m CMV Assay (P210022/S013)Abbott Molecular, Inc.2024-09-05
Alinity m HBV Assay (P200013/S022)Abbott Molecular, Inc.2024-09-05
Alinity m HR HPV Assay (P230003/S005)Abbott Molecular, Inc.2024-09-05
Alinity m CMV Assay (P210022/S011)Abbott Molecular, Inc.2024-07-10
Alinity m HR HPV Assay (P230003/S003)Abbott Molecular, Inc.2024-07-10
Alinity m HBV Assay (P200013/S020)Abbott Molecular, Inc.2024-07-10
Alinity m HR HPV (P230003/S001)Abbott Molecular, Inc.2024-02-05
Alinity m CMV (P210022/S009)Abbott Molecular, Inc.2024-02-05
Alinity m HBV (P200013/S018)Abbott Molecular, Inc.2024-02-05
Alinity m HR HPV Assay (P230003/S002)Abbott Molecular, Inc.2024-01-20
Alinity m HBV Assay (P200013/S019)Abbott Molecular, Inc.2024-01-20
Alinity m CMV Assay (P210022/S010)Abbott Molecular, Inc.2024-01-20
Alinity m CMV (P210022/S008)Abbott Molecular, Inc.2024-01-16
Alinity m HR HPV (P230003)Abbott Molecular, Inc.2023-11-01
Abbott RealTime IDH1 (P170041/S007)Abbott Molecular, Inc.2023-10-24
Alinity m HBV (P200013/S017)Abbott Molecular, Inc.2023-09-14
Alinity m CMV (P210022/S007)Abbott Molecular, Inc.2023-09-14
Alinity m HBV (P200013/S015)Abbott Molecular, Inc.2023-07-18
Alinity m CMV Assay (P210022/S005)Abbott Molecular, Inc.2023-06-16
Alinity m HBV Assay (P200013/S014)Abbott Molecular, Inc.2023-06-16
Alinity m CMV (P210022/S004)Abbott Molecular, Inc.2023-03-31
Alinity m HBV (P200013/S013)Abbott Molecular, Inc.2023-03-31
Alinity m HBV (P200013/S010)Abbott Molecular, Inc.2023-02-21
Alinity m CMV (P210022/S003)Abbott Molecular, Inc.2023-02-21
Alinity m HBV Assay (P200013/S012)Abbott Molecular, Inc.2023-01-13
Alinity m HBV (P200013/S011)Abbott Molecular, Inc.2022-12-22
Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime (P170041/S006)Abbott Molecular, Inc.2022-12-01
Alinity m CMV (P210022/S002)Abbott Molecular, Inc.2022-11-28
Alinity m HBV (P200013/S009)Abbott Molecular, Inc.2022-10-24
Alinity m HBV assay (P200013/S007)Abbott Molecular, Inc.2022-06-28
Alinity m HBV (P200013/S008)Abbott Molecular, Inc.2022-06-08
Abbott RealTime IDH1 (P170041/S004)Abbott Molecular, Inc.2022-06-02
Alinity m CMV (P210022/S001)Abbott Molecular, Inc.2022-05-26
Alinity m CMV (P210022)Abbott Molecular, Inc.2022-05-05
Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit (P170005/S004)Abbott Molecular, Inc.2022-04-11
PathVysion HER-2 DNA Probe Kit (P980024/S022)Abbott Molecular, Inc.2022-03-18
Alinity m HBV (P200013/S006)Abbott Molecular, Inc.2022-03-14
Alinity m HCV (P190025/S006)Abbott Molecular, Inc.2021-06-01
Alinity m HBV (P200013/S005)Abbott Molecular, Inc.2021-06-01
Alinity m HCV (P190025/S004)Abbott Molecular, Inc.2021-04-26
Alinity m HBV (P200013/S002)Abbott Molecular, Inc.2021-04-26
Alinity m HBV (P200013/S004)Abbott Molecular, Inc.2021-03-08
Abbott RealTime HBV (P080026/S024)Abbott Molecular, Inc.2021-03-05
Abbott RealTime HCV (P100017/S024)Abbott Molecular, Inc.2021-03-05
Alinity m HCV (P190025/S005)Abbott Molecular, Inc.2021-03-05
Alinity m HBV (P200013/S003)Abbott Molecular, Inc.2021-03-05
Abbott RealTime IDH1 (P170041/S005)Abbott Molecular, Inc.2021-03-03
Abbott RealTime IDH2 (P170005/S003)Abbott Molecular, Inc.2021-03-03
Abbott RealTime IDH1 (P170041/S003)Abbott Molecular, Inc.2021-01-19
Abbott RealTime IDH2 (P170005/S002)Abbott Molecular, Inc.2021-01-19
Alinity m HCV (P190025/S003)Abbott Molecular, Inc.2021-01-19
Alinity m HBV (P200013/S001)Abbott Molecular, Inc.2021-01-19
PathVysion HER-2 DNA Probe Kit (P980024/S021)Abbott Molecular, Inc.2020-12-11
Vysis CLL FISH Probe Kit (P150041/S006)Abbott Molecular, Inc.2020-12-11
Vysis ALK Break Apart FISH Probe Kit (P110012/S021)Abbott Molecular, Inc.2020-12-11
Abbott RealTime HCV Assay (P100017/S023)Abbott Molecular, Inc.2020-12-08
Abbott RealTime HBV Assay (P080026/S023)Abbott Molecular, Inc.2020-12-04
Alinity m HBV (P200013)Abbott Molecular, Inc.2020-08-29
Alinity m HCV (P190025/S002)Abbott Molecular, Inc.2020-06-09
Vysis ALK Break Apart Fish Probe Kit (P110012/S020)Abbott Molecular, Inc.2020-05-22
Alinity m HCV (P190025/S001)Abbott Molecular, Inc.2020-05-06
Alinity m HCV (P190025)Abbott Molecular, Inc.2020-03-23
Abbott RealTime IDH1 Assay (P170041/S002)Abbott Molecular, Inc.2019-11-12
RealTime IDH1 (P170041/S001)Abbott Molecular, Inc.2019-09-24
RealTime IDH2 (P170005/S001)Abbott Molecular, Inc.2019-09-24
Vysis ALK Break Apart FISH Probe Kit (P110012/S019)Abbott Molecular, Inc.2019-08-26
RealTime HCV (P100017/S022)Abbott Molecular, Inc.2019-05-15
RealTime HBV (P080026/S022)Abbott Molecular, Inc.2019-05-15
PathVysion HER-2 DA Probe Kit (P980024/S020)Abbott Molecular, Inc.2019-05-08
Vysis CLL FISH Probe Kit (P150041/S005)Abbott Molecular, Inc.2019-05-08
Vysis ALK Break Apart FISH Probe Kit (P110012/S018)Abbott Molecular, Inc.2019-05-08
Vysis ALK Break Apart FISH Probe Kit (P110012/S017)Abbott Molecular, Inc.2018-08-29
Vysis CLL FISH Probe Kit (P150041/S004)Abbott Molecular, Inc.2018-08-29
PathVysion HER-2 DNA Probe Kit (P980024/S019)Abbott Molecular, Inc.2018-08-29
Abbott RealTime IDH1 (P170041)Abbott Molecular, Inc.2018-07-20
Vysis ALK Break Apart FISH Probe Kit (P110012/S016)Abbott Molecular, Inc.2018-07-11
Vysis CLL FISH Probe Kit (P150041/S003)Abbott Molecular, Inc.2018-07-11
Path Vysion HER-2 DNA Probe Kit (P980024/S018)Abbott Molecular, Inc.2018-07-11
Abbott RealTime HCV Assay (P100017/S021)Abbott Molecular, Inc.2018-06-21
Vysis ALK Break Apart Fish Probe Kit (P110012/S015)Abbott Molecular, Inc.2018-03-12
Path Vysion HER-2 DNA Probe Kit (P980024/S017)Abbott Molecular, Inc.2018-03-12
Vysis CLL FISH Probe Kit (P150041/S002)Abbott Molecular, Inc.2018-03-12
Vysis CLL Fish Probe Kit (P150041/S001)Abbott Molecular, Inc.2017-12-06
Path Vysion HER-2 DNA Probe Kit (P980024/S016)Abbott Molecular, Inc.2017-12-06
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