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
- 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
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ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
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