Product code IDO
- Device name
- Microtome, Rotary
- 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 |
|---|---|---|---|
| K864733 | LKB 2260 MACROTOME | Lkb Instruments, Inc. | 1987-01-05 |
| K863548 | ROTARY MICROTOME | Surgipath Medical Industries, Inc. | 1986-09-19 |
| K843505 | LKB 2230 ROTARY ONE | Lkb Instruments, Inc. | 1984-11-30 |
| K812558 | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | Miles Laboratories, Inc. | 1981-09-29 |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | Lkb Instruments, Inc. | 1981-08-18 |
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|---|---|---|---|
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| 00860012688944 | Clarapath™ SectionStar™ | Clarapath, Inc. | 2024-10-22 |
| 00198168976302 | SectionStar | Clarapath, Inc. | 2024-08-16 |
| 05051663010528 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-05-10 |
| 05051663010559 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-05-10 |
| 05051663517898 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517904 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663517911 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-14 |
| 05051663005258 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 05051663005241 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 05051663005227 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 05051663005180 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 05051663005166 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 05051663005142 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 05051663005203 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2023-07-28 |
| 06971182570978 | MT1 Rotary Microtome | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2022-06-07 |
| 05051663010443 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-14 |
| 05051663010092 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-10 |
| 05051663010115 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-10 |
| 05051663010108 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-10 |
| 05051663010085 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-10 |
| 05051663010078 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-10 |
| 05051663005128 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2021-02-10 |
| 08720177655170 | Accu-Cut® SRM™ 200 | SAKURA FINETEK U.S.A., INC. | 2020-08-21 |
| 06971182570084 | LS-2065 Rotary Microtome | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2020-08-01 |
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| 00615233012944 | Accu-Cut® SRM™ 200 | SAKURA FINETEK U.S.A., INC. | 2020-03-31 |
| 00615233008213 | Accu-Cut® SRM™ 300 LT | SAKURA FINETEK U.S.A., INC. | 2020-02-06 |