LEB — Mounting Media Class I
FDA product code LEB covers "Mounting Media", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LEB
- 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 |
|---|---|---|---|
| K842986 | anatech | REFRAX MOUNTING MEDIUM | August 21, 1984 |
| K821019 | microbiological research | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | April 26, 1982 |
| K812193 | american scientific products | KOH MOUNTING FLUID | August 31, 1981 |
| K811799 | richard-allan medical ind | CLEAR-MOUNT | July 31, 1981 |
| K760838 | i m | LACTO-PHENOL COTTON BLUE MOUNTING FL. | November 16, 1976 |