Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- 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
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K112624
- 510(k) Type
- Traditional
- Applicant
- Roche Diagnostics
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/10/2012
- Days to Decision
- 368 days
- Submission Type
- Summary