Anesthesiology
Review Panel
- CardiovascularReview Panel
- 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
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR 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
- NQISystem, Immunomagnetic, Circulating Cancer Cell, Enumeration2Product Code
- NYIClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer2Product Code
- OVQChronic Lymphocytic Leukemia Fish Probe Kit2Product Code
- OWKEarly Growth Response 1 (Egr) Fish Probe Kit2Product Code
- OWMProstate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers2Product Code
- OXPDna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment2Product Code
- OYXBcr/Abl1 Monitoring Test2Product Code
- K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)2Cleared 510(K)
- K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems2Cleared 510(K)
- K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System2Cleared 510(K)
- K173492MRDx BCR-ABL Test, MRDx BCR-ABL Test Software2Cleared 510(K)
- DEN160003Quantidex qPCR BCR-ABL IS Kit2Cleared 510(K)
- QNCWhole Exome Sequencing Constituent Device2Product Code
- PZMNext Generation Sequencing Based Tumor Profiling Test2Product Code
- QDCDna-Based Test For Minimal Residual Disease For Hematologic Malignancies2Product Code
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K190076
- 510(k) Type
- Traditional
- Applicant
- Cepheid
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/27/2019
- Days to Decision
- 254 days
- Submission Type
- Summary