Product code LDY
- Device name
- Fixative, Formalin-Containing
- 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 |
|---|---|---|---|
| K880549 | DIACYTE FIXATIVE SOLUTION | Cytocorp, Inc. | 1988-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00846338003760 | Endiscope and accessories | ELLIQUENCE, LLC | 2026-05-07 |
| 00846338003777 | Endiscope and accessories | ELLIQUENCE, LLC | 2026-05-07 |
| 00846338003784 | Endiscope and accessories | ELLIQUENCE, LLC | 2026-05-07 |
| 00846338003746 | Endiscope and accessories | ELLIQUENCE, LLC | 2026-05-07 |
| 00673693167505 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-10-22 |
| 00673693235846 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693236607 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693236591 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693236577 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693228336 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693228329 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693228312 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693080033 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-25 |
| 00673693084338 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693737906 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693576123 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693236560 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693228305 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693177788 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693088428 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693084543 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693084499 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693084406 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693084260 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693084222 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693079891 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00845275004939 | Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2016-09-16 |
| 00845275004946 | Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2016-09-16 |
| 00845275004953 | Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2016-09-16 |
| 00845275004960 | Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2016-09-16 |