Microtome, Sliding
Sliding Microtome is a laboratory instrument used in pathology to cut thin, uniform tissue sections from paraffin-embedded or other specimen blocks by advancing a fixed knife across a sliding specimen holder, enabling precise section thickness for microscopic examination. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFL, regulated under 21 CFR 864.3010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KFL
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.