LDY — Fixative, Formalin-Containing Class I
FDA product code LDY covers "Fixative, Formalin-Containing", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LDY
- 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 |
|---|---|---|---|
| K880549 | cytocorp | DIACYTE FIXATIVE SOLUTION | April 1, 1988 |