Anesthesiology
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- 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)
- PSUJak2 Gene Mutation Detection Test2Product Code
- QAZCancer Predisposition Risk Assessment System2Product Code
- 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
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- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
Quantidex qPCR BCR-ABL IS Kit
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN160003
- 510(k) Type
- Direct
- Applicant
- Asuragen, Inc.
- Country
- United States
- FDA Decision
- Deleted
- Decision Date
- 7/22/2016
- Days to Decision
- 185 days