Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- DHXSystem, Test, Carcinoembryonic Antigen2Product Code
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer2Product Code
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers2Product Code
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)2Product Code
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder2Product Code
- MOISystem, Test, Immunological, Antigen, Tumor2Product Code
- MSWSystem, Test, Thyroglobulin2Product Code
- MUTKit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)2Product Code
- NCWSystem, Test, Her-2/Neu, Monitoring2Product Code
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer2Product Code
- NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment2Product Code
- NTYSystem, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer2Product Code
- NVACancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma2Product Code
- OAUDes-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma2Product Code
- OIUTest, Epithelial Ovarian Tumor Associated Antigen (He4)2Product Code
- K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators2Cleared 510(K)
- K112624ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 52Cleared 510(K)
- K103676FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL2Cleared 510(K)
- K093957ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,2Cleared 510(K)
- K072939HE4 EIA, MODEL: 404-10 US2Cleared 510(K)
- OVKCytokeratin Fragments 21-1 Eia Kit2Product Code
- ONXOvarian Adnexal Mass Assessment Score Test System2Product Code
- QTEThymidine Kinase Activity2Product Code
- QXSChromogranin A2Product Code
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Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K151378
- 510(k) Type
- Traditional
- Applicant
- Fujirebio Diagnostics,Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/24/2015
- Days to Decision
- 186 days
- Submission Type
- Summary