Preservative, Cytological
A cytological preservative is a pathology reagent used to stabilize cells in specimens collected for cytological examination, such as cervical smears or fine needle aspiration samples, preventing cellular degradation before laboratory processing. It is classified as FDA Class 1, subject only to general controls, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is LEA, regulated under 21 CFR 864.4010, in the Pathology specialty. No premarket notification is required.
Basic Information
- Product Code
- LEA
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K873594 | TIF FECAL TEST | Sep 29, 1987 | Substantially Equivalent | Devetec, Inc. |
| K770592 | CYTOLOGY FIXATIVE | May 20, 1977 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K761001 | PAP-TRAY II (CATALOG #C600-2) | Dec 06, 1976 | Substantially Equivalent | Lerner Laboratories, Inc. |
| K761000 | PAP-TRAY I (CATALOG #C600-1) | Dec 06, 1976 | Substantially Equivalent | Lerner Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.