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
- K210973MammaPrint FFPE NGS Kit2Cleared 510(K)
- K201902MammaPrint2Cleared 510(K)
- K141142MAMMAPRINT FFPE2Cleared 510(K)
- K141771PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY2Cleared 510(K)
- K130010PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY2Cleared 510(K)
- K101454MAMMAPRINT2Cleared 510(K)
- K081092MODIFICATION TO MAMMAPRINT2Cleared 510(K)
- K080252MODIFICATION TO MAMMAPRINT2Cleared 510(K)
- K070675MAMMAPRINT2Cleared 510(K)
- DEN070009MAMMAPRINT2Cleared 510(K)
- 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
- 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
MammaPrint FFPE NGS Kit
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K210973
- 510(k) Type
- Traditional
- Applicant
- Agendia Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/8/2022
- Days to Decision
- 526 days
- Submission Type
- Summary