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Clinical Toxicology

56 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027)Hologic, Inc.2024-12-06
AvertD and AvertD Buccal Sample Collection Kit (P230032/S002)AutoGenomics, Inc.2024-11-07
TLiIQ QCette (P920048/S026)Hologic, Inc.2024-10-23
AvertD and AvertD Buccal Sample Collection Kit (P230032/S001)AutoGenomics, Inc.2024-02-16
Rapid fFN for the TLiIQ System (P920048/S025)Hologic, Inc.2023-12-21
AvertD and AvertD Buccal Sample Collection Kit (P230032)AutoGenomics, Inc.2023-12-19
Rapid fFN for the TLilQ System (P920048/S024)Hologic, Inc.2023-08-24
Rapid fFN for the TLiIQ System (P920048/S023)Hologic, Inc.2022-05-09
Rapid fFN for the TLiIQ System (P920048/S022)Hologic, Inc.2022-04-13
Rapid fFN for the TLiIQ System (P920048/S021)Hologic, Inc.2022-02-28
Rapid fFN for the TLiIQ System (P920048/S019)Hologic, Inc.2021-05-21
Rapid fFN for the TLilQ System (P920048/S020)Hologic, Inc.2021-04-29
Rapid fFN for the TLiIQ System (P920048/S015)Hologic, Inc.2020-11-06
Rapid fFN for the TLiIQ System (P920048/S018)Hologic, Inc.2020-10-02
Rapid fFN for the TLiIQ System (P920048/S016)Hologic, Inc.2020-09-03
Rapid fFN for the TLiIQ System (P920048/S017)Hologic, Inc.2020-08-12
Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay (P920048/S013)Hologic, Inc.2020-01-28
PartoSure Test (P160052/S001)Qiagen, Inc.2019-10-11
Rapid fFN for the TLiIQ System (P920048/S014)Hologic, Inc.2018-12-17
PartoSure test (P160052)Qiagen, Inc.2018-04-11
TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD (P890025/S013)Abbott Laboratories2002-09-05
IMX TACROLIMUS II (P970007/S003)Abbott Laboratories2002-09-05
IMX TACROLIMUS II (P970007/S004)Abbott Laboratories2002-09-05
TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD (P890025/S014)Abbott Laboratories2002-09-05
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
IMX TACROLIMUS II (P970007/S002)Abbott Laboratories2001-03-30
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD (P890025/S012)Abbott Laboratories1999-09-29
ABBOTT IMX TACROLIMUS II (P970007/S001)Abbott Laboratories1999-09-22
PRO-TRAC II TACROLIMUS ELISA KIT (P970025)DiaSorin, Inc.1999-04-27
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S010)Abbott Laboratories1998-02-13
IMX TACROLIMUS II ASSAY (P970007)Abbott Laboratories1997-08-26
DR. BROWN'S HOME DRUG TESTING KIT (P950040/S003)Personal Health & Hygiene, Inc.1997-08-15
DR. BROWN'S HOME DRUG TESTING KIT (P950040/S001)Personal Health & Hygiene, Inc.1997-02-26
DR. BROWN'S HOME DRUG TESTING KIT (P950040/S002)Personal Health & Hygiene, Inc.1997-02-05
DR. BROWN'S HOME DRUG TESTING KIT (P950040)Personal Health & Hygiene, Inc.1997-01-21
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S009)Abbott Laboratories1996-04-01
FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK) (P920048)Hologic, Inc.1995-09-21
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S008)Abbott Laboratories1994-03-31
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S004)Abbott Laboratories1992-12-17
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S005)Abbott Laboratories1992-12-17
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S007)Abbott Laboratories1992-12-15
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S006)Abbott Laboratories1992-12-15
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S003)Abbott Laboratories1992-03-18
1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS (P890065/S001)DiaSorin, Inc.1991-01-30
TDX CYCLOSPORINE AND METABOLITES WHOLE BLOOD ASSAY (P890025/S002)Abbott Laboratories1990-10-04
CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS (P890065)DiaSorin, Inc.1990-09-28
TDX CYCLOSPORINE AND METABOLITES SERUM ASSAY (P890025/S001)Abbott Laboratories1990-05-04
TD CYCLOSPORINE AND METABOLITES SERUM ASSAY (P890025)Abbott Laboratories1989-12-14

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