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Gen-Probe Incorporated

86 FDA 510(k) clearances · PMA applicant

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◉ Watch Gen-Probe Incorporated

RecordFirmDate
Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass (P120007/S033)Gen-Probe Incorporated2025-10-07
Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A (P100042/S039)Gen-Probe Incorporated2025-10-07
Aptima HPV-GT Assay (P120007/S032)Gen-Probe Incorporated2024-10-23
Aptima HPV Assay (P100042/S037)Gen-Probe Incorporated2024-10-23
Aptima HPV-GT Assay (P120007/S031)Gen-Probe Incorporated2024-07-26
Aptima HPV Assay (P100042/S036)Gen-Probe Incorporated2024-07-26
Aptima HPV Assay (P100042/S035)Gen-Probe Incorporated2023-07-07
Aptima HPV 16 18/45 Genotype Assay (P120007/S030)Gen-Probe Incorporated2023-06-02
Aptima HPV Assay (P100042/S034)Gen-Probe Incorporated2023-06-02
Aptima HPV Assay (P100042/S032)Gen-Probe Incorporated2022-02-25
Aptima HPV 16 18/45 Genotype Assay (P120007/S029)Gen-Probe Incorporated2022-02-25
Aptima HPV Assay (P100042/S033)Gen-Probe Incorporated2022-01-28
Aptima HPV Assay (P100042/S031)Gen-Probe Incorporated2020-07-21
Aptima HPV 16 18/45 Genotype Assay (P120007/S028)Gen-Probe Incorporated2020-07-21
Progensa PCA3 Assay (P100033/S012)Gen-Probe Incorporated2020-07-21
Aptima HPV 16 18/45 Genotype Assay (P120007/S027)Gen-Probe Incorporated2020-06-11
Aptima HPV Assay (P100042/S030)Gen-Probe Incorporated2020-06-11
Progensa PCA3 Assay (P100033/S011)Gen-Probe Incorporated2020-06-08
Aptima HPV 16 18/45 Genotype Assay (P120007/S025)Gen-Probe Incorporated2020-04-27
Aptima HPV Assay (P100042/S027)Gen-Probe Incorporated2020-04-27
Aptima HPV Assay (P100042/S029)Gen-Probe Incorporated2020-02-10
Aptima HPV Assay (P100042/S028)Gen-Probe Incorporated2020-01-21
Aptima HPV 16 18/45 Genotype Assay (P120007/S026)Gen-Probe Incorporated2020-01-21
Aptima HPV 16 18/45 Genotype Assay (P120007/S022)Gen-Probe Incorporated2019-12-16
Aptima HPV Assay (P100042/S024)Gen-Probe Incorporated2019-12-16
Aptima HPV 16 18/45 Genotype Assay (P120007/S024)Gen-Probe Incorporated2019-09-16
Aptima HPV Assay (P100042/S026)Gen-Probe Incorporated2019-09-16
Aptima HPV 16 18/45 Genotype Assay (P120007/S023)Gen-Probe Incorporated2019-08-27
Aptima HPV Assay (P100042/S025)Gen-Probe Incorporated2019-08-27
APTIMA HPV 16 18/45 Genotype Assay (P120007/S020)Gen-Probe Incorporated2019-04-28
APTIMA HPV Assay (P100042/S022)Gen-Probe Incorporated2019-04-28
APTIMA HPV 16 18/45 Genotype Assay (P120007/S021)Gen-Probe Incorporated2019-04-26
APTIMA HPV ASSAY (P100042/S023)Gen-Probe Incorporated2019-04-26
Aptima HPV 16 18/45 Genotype Assay (P120007/S019)Gen-Probe Incorporated2019-04-22
Aptima HPV Assay (P100042/S021)Gen-Probe Incorporated2019-03-21
Progensa PCA3 Assay (P100033/S010)Gen-Probe Incorporated2019-03-15
Aptima HPV 16 18/45 Genotype Assay (P120007/S018)Gen-Probe Incorporated2019-02-28
Aptima HPV Assay (P100042/S020)Gen-Probe Incorporated2019-02-28
Progensa PCA3 Assay (P100033/S009)Gen-Probe Incorporated2018-10-18
Aptima HPV Assay (P100042/S019)Gen-Probe Incorporated2018-09-28
Aptima HPV 16 18/45 Genotype Assay (P120007/S017)Gen-Probe Incorporated2018-09-28
Aptima HPV Assay (P100042/S018)Gen-Probe Incorporated2018-09-13
Aptima HPV 16 18/45 Genotype Assay (P120007/S016)Gen-Probe Incorporated2018-09-13
Aptima HPV 16 18/45 Genotype Assay (P120007/S015)Gen-Probe Incorporated2018-04-13
Aptima HPV Assay (P100042/S017)Gen-Probe Incorporated2018-04-13
Aptima HPV 16 18/45 Genotype Assay (P120007/S014)Gen-Probe Incorporated2018-03-08
Aptima HPV Assay (P100042/S016)Gen-Probe Incorporated2018-03-08
Progensa PCA3 Assay (P100033/S008)Gen-Probe Incorporated2018-03-07
Aptima HPV Assay (P100042/S013)Gen-Probe Incorporated2018-02-28
Aptima HPV 16 18/45 Genotype Assay (P120007/S011)Gen-Probe Incorporated2018-02-23
Aptima HPV 16 18/45 Genotype Assay (P120007/S013)Gen-Probe Incorporated2018-01-18
Aptima HPV Assay (P100042/S015)Gen-Probe Incorporated2018-01-18
Progensa PCA3 Assay (P100033/S007)Gen-Probe Incorporated2017-11-03
Aptima HPV Assay (P100042/S014)Gen-Probe Incorporated2017-11-03
Aptima HPV 16 18/45 Genotype Assay (P120007/S012)Gen-Probe Incorporated2017-11-03
Aptima HPV Assay (P100042/S012)Gen-Probe Incorporated2017-05-04
Aptima HPV 16 18/45 Genotype Assay. (P120007/S010)Gen-Probe Incorporated2017-05-04
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S006)Gen-Probe Incorporated2016-09-19
APTIMA HPV ASSAY (P100042/S008)Gen-Probe Incorporated2016-09-19
APTIMA HPV ASSAY (P100042/S011)Gen-Probe Incorporated2016-09-13
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S009)Gen-Probe Incorporated2016-09-13
APTIMA HPV ASSAY (P100042/S010)Gen-Probe Incorporated2016-05-20
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S008)Gen-Probe Incorporated2016-03-28
APTIMA HPV ASSAY (P100042/S007)Gen-Probe Incorporated2015-11-24
PROGENSA PCA3 ASSAY (P100033/S004)Gen-Probe Incorporated2015-11-12
APTIMA HPV ASSAY (P100042/S009)Gen-Probe Incorporated2015-11-09
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S007)Gen-Probe Incorporated2015-11-09
PROGENSA PCA3 ASSAY (P100033/S006)Gen-Probe Incorporated2015-09-24
PROGENSA PCA3 ASSAY (P100033/S005)Gen-Probe Incorporated2015-07-09
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S003)Gen-Probe Incorporated2015-06-05
APTIMA HPV ASSAY (P100042/S004)Gen-Probe Incorporated2015-06-05
PROGENSA PCA3 ASSAY (P100033/S003)Gen-Probe Incorporated2015-04-16
APTIMA HPV ASSAY (P100042/S005)Gen-Probe Incorporated2015-04-01
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S004)Gen-Probe Incorporated2015-04-01
PROGENSA PCA3 ASSAY (P100033/S002)Gen-Probe Incorporated2015-01-21
APTIMA HPV ASSAY (P100042/S003)Gen-Probe Incorporated2014-07-07
APTIMA HPV ASSAY (P100042/S002)Gen-Probe Incorporated2014-04-29
APTIMA HPV 16 18/45 GENETYPE ASSAY (P120007/S002)Gen-Probe Incorporated2014-04-29
PROGENSA PCA3 ASSAY (P100033/S001)Gen-Probe Incorporated2013-12-12
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S001)Gen-Probe Incorporated2013-11-06
APTIMA HPV ASSAY (P100042/S001)Gen-Probe Incorporated2013-07-15
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007)Gen-Probe Incorporated2012-10-12
PROGENSA PCA3 ASSAY (P100033)Gen-Probe Incorporated2012-02-13
APTIMA HPV ASSAY (P100042)Gen-Probe Incorporated2011-10-28

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Every clearance here is in the API, with alerts when new ones post.