Anesthesiology
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- HematologyReview Panel
- ImmunologyReview 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
- K080751ARCHITECT CYCLOSPORINE2Cleared 510(K)
- K071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR2Cleared 510(K)
- K081992DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K41082Cleared 510(K)
- K062236DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE2Cleared 510(K)
- K053061EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY2Cleared 510(K)
- K052017CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF1082Cleared 510(K)
- K040761AXSYM CYCLOSPORINE2Cleared 510(K)
- K023208CEDIA CYCLOSPORINE PLUS ASSAY2Cleared 510(K)
- K023065CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE2Cleared 510(K)
- P920031EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYAPRLPMA Approval
- MLMEnzyme Immunoassay, Tracrolimus2Product Code
- 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
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- DADE BEHRING, INC.
- Trade Name
- EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- Generic Name
- CYCLOSPORINE
- Decision Date
- 10/2/1996
- Days to Decision
- 1556 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval