Product code LEA
- Device name
- Preservative, Cytological
- 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 |
|---|---|---|---|
| K873594 | TIF FECAL TEST | Devetec, Inc. | 1987-09-29 |
| K770592 | CYTOLOGY FIXATIVE | Surgipath Medical Industries, Inc. | 1977-05-20 |
| K761000 | PAP-TRAY I (CATALOG #C600-1) | Lerner Laboratories, Inc. | 1976-12-06 |
| K761001 | PAP-TRAY II (CATALOG #C600-2) | Lerner Laboratories, Inc. | 1976-12-06 |
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|---|---|---|---|
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| 09551020410443 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
| 09551020410436 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
| 09551020410283 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
| 09551020410252 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
| 09551020410245 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
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| 09551020410221 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
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| 09551020410115 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
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| 09551020410030 | PathTezt® | BIOCYTECH CORPORATION SDN. BHD. | 2026-03-11 |
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| 20613647028623 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
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| 00849832002949 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-27 |
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| 00810160180357 | SUPMEDIC | Supmedics Inc. | 2024-11-04 |
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| 10844509000850 | Streck Cell Preservative | STRECK, INC. | 2016-09-19 |
| 10844509000843 | Streck Cell Preservative | STRECK, INC. | 2016-09-19 |