Filters, Cell Collection, Tissue Processing
Cell Collection and Tissue Processing Filters are laboratory devices used in pathology to collect cellular material from fluid specimens or to filter tissue suspensions during processing, enabling concentration of cells for cytological or histological 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 KET, 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
- KET
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Jan 12, 1988 | Substantially Equivalent | Corning Medical & Scientific |
| K870196 | PCTE MICROPOROUS MEMBRANE FILTER | May 12, 1987 | Substantially Equivalent | Poretics Corp. |
| K844671 | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | Feb 25, 1985 | Substantially Equivalent | Corning Medical & Scientific |
| K840556 | DISPOSABLE SYRINGE FILTERS | Mar 05, 1984 | Substantially Equivalent | Corning Medical & Scientific |
| K792633 | STERILIZATION PROCESS/OUTERWRAP | Jan 11, 1980 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.