Cytocentrifuge
A cytocentrifuge is a laboratory centrifuge specifically designed to deposit cells from liquid specimens directly onto glass microscope slides, producing a concentrated monolayer cell preparation for cytological examination and staining. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IFB, regulated under 21 CFR 864.3300, in the Pathology medical specialty.
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Basic Information
- Product Code
- IFB
- Device Class
- FDA class 1
- Regulation Number
- 864.3300
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K852117 | CYTO-TEK CENTRIFUGE | Jun 10, 1985 | Substantially Equivalent | Miles Laboratories, Inc. |
| K810848 | CYTOBUCKET MODEL 1024 | Apr 23, 1981 | Substantially Equivalent | Cytochem, Inc. |
| K792032 | LEIF CENTRIFUGAL CYTOLOGY BUCKET | Nov 30, 1979 | Substantially Equivalent | Robert C. Leif, Ph.D. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.