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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
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- ImmunologyReview Panel
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- MiscellaneousMiscellaneous
- PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection2Product Code
- PSUJak2 Gene Mutation Detection Test2Product Code
- QAZCancer Predisposition Risk Assessment System2Product Code
- QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies2Product Code
- MAODna-Probe, Human ChromosomeUProduct Code
- MKQProcessor, Cervical Cytology Slide, Automated3Product Code
- MNMReader, Cervical Cytology Slide, Automated3Product Code
- MTIKit, Cell Screening, FetalNProduct Code
- MVCSystem, Test, Her-2/Neu, Ihc3Product Code
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum3Product Code
- NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence3Product Code
- NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion3Product Code
- OQSLaboratory Developed TestNProduct Code
- OTUResearch Use Only/PathologyNProduct Code
- OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement3Product Code
- PANBraf Mutation KitNProduct Code
- PDDInvestigational Use Only - PathologyNProduct Code
- PFUTissue Processing KitNProduct Code
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection3Product Code
- PJGCancer-Related Germline Gene Mutation Detection System3Product Code
- PKWImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase3Product Code
- PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 13Product Code
- PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System3Product Code
- P240010MI Cancer SeekAPPRPMA Approval
- P230011TruSight Oncology ComprehensiveAPPRPMA Approval
- P210011xT CDxAPPRPMA Approval
- P210040RESOLUTION ctDx FIRSTAPPRPMA Approval
- P200011ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)APPRPMA Approval
- P200016FoundationOne Liquid CDxAPPRPMA Approval
- P200006FoundationOne Liquid CDx (F1 Liquid CDx)APPRPMA Approval
- P190032FoundationOne Liquid CDx (F1 Liquid CDx)APPRPMA Approval
- P200010Guardant360 CDxAPPRPMA Approval
- P170019FoundationOne CDxAPPRPMA Approval
Show All 13 Submissions
- QFISynthetic Next-Generation Sequencing Quality Control And Filler MaterialNProduct Code
- QFKTumor Gene Profiling TestNProduct Code
- QQTImmunohistochemistry Assay, Antibody, Ki-673Product Code
- QSACirculating Tumor Cell (Ctc) Enrichment Device2Product Code
- QVUHigh Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.2Product Code
- QYVDigital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm2Product Code
- SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection3Product Code
- SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- 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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- UnknownReview Panel
Guardant360 CDx
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Guardant Health, Inc.
- Trade Name
- Guardant360 CDx
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision Date
- 8/7/2020
- Days to Decision
- 179 days
- Decision Code
- APPR
- FDA Decision
- Approval