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
- NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays2Product Code
- K130775DUET SYSTEM2Cleared 510(K)
- K122554GENASIS SCANVIEW SYSTEM2Cleared 510(K)
- K110345SCANVIEW SYSTEM2Cleared 510(K)
- K101291SCANVIEW HER2/NEU FISH SYSTEM2Cleared 510(K)
- K080909ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 20002Cleared 510(K)
- K043519ARIOL HER-2/NEU FISH2Cleared 510(K)
- K042542CYTOVISION FOR CEP XY2Cleared 510(K)
- DEN040010VYSIS AUTOVYSION SYSTEM2Cleared 510(K)
- NTWSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test2Product Code
- OYUDna-Probe Kit, Human Chromosome2Product Code
- OZFTissue Rna Preservative For Collection, Storage, And Transportation2Product Code
- 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
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
VYSIS AUTOVYSION SYSTEM
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN040010
- 510(k) Type
- Post-NSE
- Applicant
- Vysis
- Country
- United States
- FDA Decision
- Deleted
- Decision Date
- 12/13/2004
- Days to Decision
- 61 days