Anesthesiology
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- LTBCyclosporine Radioimmunoassay2Product Code
- MARCyclosporine And Metabolites Serum Assay2Product Code
- MGSHigh Performance Liquid Chromatography For Cyclosporine2Product Code
- MGUFluorescence Polarization Immunoassay For Cyclosporine2Product Code
- MGVRadioimmunoassay For Cyclosporine2Product Code
- MKWCyclosporine2Product Code
- MLMEnzyme Immunoassay, Tracrolimus2Product Code
- K203833Tacrolimus Assay Kit2Cleared 510(K)
- K173857Elecsys Tacrolimus2Cleared 510(K)
- K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)2Cleared 510(K)
- K123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS2Cleared 510(K)
- K070820ARCHITECT TACROLIMUS: MODEL 1L772Cleared 510(K)
- K063868MASSTRAK IMMUNOSUPPRESSANTS KIT2Cleared 510(K)
- K060502DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF1072Cleared 510(K)
- K060385EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT2Cleared 510(K)
- K050206CEDIA TACROLIMUS ASSAY2Cleared 510(K)
- P970025PRO-TRAC II TACROLIMUS ELISA KITAPRLPMA Approval
- P970007IMX TACROLIMUS II2PMA Approval
- P970007IMX TACROLIMUS II2PMA Approval
- P970007ABBOTT IMX TACROLIMUS II2PMA Approval
- P970025PRO-TRAC II TACROLIMUS ELISA KIT2PMA Approval
- P970007IMX TACROLIMUS II ASSAY2PMA Approval
- NFXTest, Cholesterol, Total, Over The Counter1Product Code
- NFZTest, Creatinine, Over The Counter2Product Code
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter1Product Code
- NGDTest, Lactic Acid, Over The Counter1Product Code
- NGETest, Luteinizing Hormone (Lh), Over The Counter1Product Code
- NGJTest, Nitrite, Urinary, Non-Quantitative, Over The Counter1Product Code
- NGOTest, Triglycerides, Over The Counter1Product Code
- PQOAnti-Müllerian Hormone Test System2Product Code
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter1Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
IMX TACROLIMUS II
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Laboratories
- Trade Name
- IMX TACROLIMUS II ASSAY
- Generic Name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Decision Date
- 8/26/1997
- Days to Decision
- 189 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval