FDA product code LEB: Mounting Media
LEB is the FDA product code for mounting media. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under LEB, from 5 different applicants. The average 510(k) review took 27 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Mounting Media |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LEB clearance
Top LEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anatech, Ltd. | 1 | 1984-08-21 |
| Microbiological Research Corp. | 1 | 1982-04-26 |
| American Scientific Products | 1 | 1981-08-31 |
| Richard-Allan Medical Ind., Inc. | 1 | 1981-07-31 |
| I M, Inc. | 1 | 1976-11-16 |
Most recent LEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842986 | Anatech, Ltd. | REFRAX MOUNTING MEDIUM | 1984-08-21 | 22 |
| K821019 | Microbiological Research Corp. | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | 1982-04-26 | 14 |
| K812193 | American Scientific Products | KOH MOUNTING FLUID | 1981-08-31 | 28 |
| K811799 | Richard-Allan Medical Ind., Inc. | CLEAR-MOUNT | 1981-07-31 | 37 |
| K760838 | I M, Inc. | LACTO-PHENOL COTTON BLUE MOUNTING FL. | 1976-11-16 | 34 |
Recalls for LEB devices
openFDA lists no recalls for product code LEB.
Frequently asked questions
What is FDA product code LEB?
LEB is the FDA product code for mounting media. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is LEB?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LEB?
Across 5 cleared submissions the average was 27 days from receipt to decision (median 28).
Which companies have the most LEB clearances?
Anatech, Ltd. (1); Microbiological Research Corp. (1); American Scientific Products (1); Richard-Allan Medical Ind., Inc. (1); I M, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEB
- Run a recall and safety report across every LEB manufacturer
- Watch product code LEB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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