Product code IEO
- Device name
- Processor, Tissue, Automated
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3875
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Innovative Medical Systems, Inc. | 1992-12-29 |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Innovative Medical Systems, Inc. | 1988-09-02 |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Sakura Finetek U.S.A., Inc. | 1988-07-01 |
| K853938 | LX 300 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | 1985-10-10 |
| K851054 | LX120 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | 1985-05-15 |
| K843506 | LKB 2189 ULTROPROCESSOR | Lkb Instruments, Inc. | 1984-11-30 |
| K834599 | AUTOTECHNICON V TISSUE PROCESS SYS | Technicon Instruments Corp. | 1984-02-04 |
| K831313 | TISSUE-TEK V.I.P. 100/200 | Miles Laboratories, Inc. | 1983-07-28 |
| K801427 | TISSUE-TEK III MINI-RAPID PROCESSOR | Miles Laboratories, Inc. | 1980-07-28 |
| K801513 | TISSUE PROCESSING SYSTEM | Innovative Medical Systems, Inc. | 1980-07-28 |
| K771308 | TISSUE-TEK III V.I.P. | Miles Laboratories, Inc. | 1977-08-22 |
| K761062 | HISTO-TEK W/ AUTOMATIC COVERSLIPPER | Miles Laboratories, Inc. | 1977-03-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09551020410009 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
| 09551020410016 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
| 04946433600584 | Tissue-VIP® 6 AI | SAKURA FINETEK U.S.A., INC. | 2024-10-11 |
| 05051663518581 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-06-13 |
| 05051663518598 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-06-13 |
| 05051663518604 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-06-13 |
| 05051663517331 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517867 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517850 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517683 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517621 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517614 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517607 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517577 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517553 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517546 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517355 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517348 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517324 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517317 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517294 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 09349458005580 | HistoCore PELORIS | LEICA BIOSYSTEMS MELBOURNE PTY LTD | 2023-08-30 |
| 09349458005573 | HistoCore PELORIS | LEICA BIOSYSTEMS MELBOURNE PTY LTD | 2023-08-30 |
| 05051663009386 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| B92114709 | HistoPro® | RUSHABH INSTRUMENTS, LLC | 2022-12-18 |
| 10615233013412 | Tissue-Tek VIP® | SAKURA FINETEK U.S.A., INC. | 2020-02-23 |
| 04049188210777 | ASP6025 S 230V/50-60Hz | Leica Biosystems Nussloch GmbH | 2019-07-05 |
| 04049188210784 | ASP6025 S 120V/50-60Hz | Leica Biosystems Nussloch GmbH | 2019-07-05 |
| 04049188210791 | ASP6025 S China | Leica Biosystems Nussloch GmbH | 2019-07-05 |
| 08052478980690 | PATHOS DELTA | MILESTONE SRL | 2018-09-24 |