Product code IDP
- Device name
- Microtome, Cryostat
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3010
- 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 |
|---|---|---|---|
| K883514 | EXAKT CUTTING & GRINDING SYSTEM | Exakt Medical Instruments, Inc. | 1988-08-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051663011518 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2025-11-07 |
| 05051663011501 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2025-11-07 |
| 05051663011112 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2025-08-26 |
| 05051663011129 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2025-08-26 |
| 06971182571258 | CT520 Cryostat Microtome | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2024-12-27 |
| 05051663003551 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003872 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003865 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003629 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003605 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003599 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003582 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003544 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003537 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003520 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-15 |
| 05051663003889 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-08-09 |
| 05051663005456 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-08-09 |
| 05051663005432 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-08-09 |
| 05051663003896 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-08-09 |
| 05051663003469 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003476 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003483 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003490 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003506 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003513 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003568 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003575 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003612 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003636 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |
| 05051663003643 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-26 |