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
- IEOProcessor, Tissue, Automated1Product Code
- IFBCytocentrifuge1Product Code
- IBJLight, Microscope1Product Code
- IBKMicroscope, Fluorescence/U.V.1Product Code
- IBLMicroscope, Inverted Stage, Tissue Culture1Product Code
- IBMMicroscope, Phase Contrast1Product Code
- IDLMicrotome, Accessories1Product Code
- IDMMicrotome, Ultra1Product Code
- IDNMicrotome, Freezing Attachment1Product Code
- IDOMicrotome, Rotary1Product Code
- IDPMicrotome, Cryostat1Product Code
- IDQInfiltrator1Product Code
- IDROvens, Paraffin1Product Code
- IDSMelting Pot, Paraffin1Product Code
- IDTApparatus, Melting Point, Paraffin1Product Code
- IDWDispensers, Paraffin1Product Code
- IDXSieves, Tissue1Product Code
- IDYBath, Flotation, Tissue1Product Code
- IDZCassettes, Tissue1Product Code
- IEGTable, Slide Warming1Product Code
- IEHLamps, Slide Warming1Product Code
- IHJBlender, Sputum1Product Code
- KDTContainer, Specimen Mailer And Storage, Sterile1Product Code
- KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile1Product Code
- KDZDevice, Decalcifier, Electrolytic1Product Code
- KEGLamps, Microscope1Product Code
- KEHMicrometers, Microscope1Product Code
- KEICondensers, Microscope1Product Code
- KEJStages, Microscope1Product Code
- KERContainer, Embedding1Product Code
- KESCoverslips, Microscope Slide1Product Code
- KETFilters, Cell Collection, Tissue Processing1Product Code
- KEWSlides, Microscope1Product Code
- KEYStainer, Tissue, Automated1Product Code
- KFLMicrotome, Sliding1Product Code
- KIMDevice For Sealing Microsections1Product Code
- KINSlide Stainer, Contact Type1Product Code
- KIOSlide Stainer, Immersion Type1Product Code
- KJGTube, Tissue Culture1Product Code
- KPASlide Stainer, Automated1Product Code
- LECGrinder, Tissue1Product Code
- MJISpecimen/Tissue, Identification Orientation1Product Code
- NNKContainer, Specimen Mailer And Storage, Non-Sterile1Product Code
- NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile1Product Code
- PSYWhole Slide Imaging System2Product Code
- PZZDigital Pathology Display2Product Code
- QKQDigital Pathology Image Viewing And Management Software2Product Code
- K242244Viewer+2Cleared 510(K)
- K241273FullFocus2Cleared 510(K)
- K240303MetaLite DX Digital Pathology Software2Cleared 510(K)
- K233126aetherSlide2Cleared 510(K)
- K212361Novo2Cleared 510(K)
- K210811Dynamyx Digital Pathology Software2Cleared 510(K)
- K201005FullFocus2Cleared 510(K)
- K193054Sectra Digital Pathology Module2Cleared 510(K)
- QPNSoftware Algorithm Device To Assist Users In Digital Pathology2Product Code
- 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
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Sectra Digital Pathology Module
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K193054
- 510(k) Type
- Traditional
- Applicant
- Sectra AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/31/2020
- Days to Decision
- 151 days
- Submission Type
- Summary