LEA — Preservative, Cytological Class I
FDA product code LEA covers "Preservative, Cytological", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LEA
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K873594 | devetec | TIF FECAL TEST | September 29, 1987 |
| K770592 | surgipath medical industries | CYTOLOGY FIXATIVE | May 20, 1977 |
| K761000 | lerner laboratories | PAP-TRAY I (CATALOG #C600-1) | December 6, 1976 |
| K761001 | lerner laboratories | PAP-TRAY II (CATALOG #C600-2) | December 6, 1976 |