Product code LEB
- Device name
- Mounting Media
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.4010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842986 | REFRAX MOUNTING MEDIUM | Anatech, Ltd. | 1984-08-21 |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Microbiological Research Corp. | 1982-04-26 |
| K812193 | KOH MOUNTING FLUID | American Scientific Products | 1981-08-31 |
| K811799 | CLEAR-MOUNT | Richard-Allan Medical Ind., Inc. | 1981-07-31 |
| K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. | I M, Inc. | 1976-11-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049016151982 | Mounting medium (IIFT) | EUROIMMUN Medizinische Labordiagnostika AG | 2025-07-03 |
| 04049016152002 | Mounting medium (IIFT) | EUROIMMUN Medizinische Labordiagnostika AG | 2025-07-03 |
| 00613647028650 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 20613647028616 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 20613647028654 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00613647028612 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00860012688937 | ClaraMountâ„¢ Coverslip mounting medium | Clarapath, Inc. | 2024-08-23 |
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