Grinder, Tissue
A tissue grinder is a pathology laboratory instrument used to mechanically homogenize and disaggregate tissue samples for subsequent biochemical analysis, culture, or histological processing. It is classified as FDA Class 1, the lowest risk category, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is LEC, regulated under 21 CFR 864.3010, in the Pathology specialty. No premarket notification is required.
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Basic Information
- Product Code
- LEC
- 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 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.