Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
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- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
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- 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
- 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
- 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
- Physical MedicineReview Panel
- RadiologyReview Panel
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- UnknownReview Panel
Slide Stainer, Automated
- Page Type
- Product Code
- Regulation Medical Specialty
- Pathology
- Review Panel
- Pathology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 864.3800
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.3800 Automated slide stainer
§ 864.3800 Automated slide stainer.
(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]