Product code KEO
- Device name
- Formulations, Paraffin, All
- 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 |
|---|---|---|---|
| K893772 | TISSUE EMBEDDING MEDIUM | Stephens Scientific | 1989-06-22 |
| K862223 | MICRO THIN* PARAFFIN | Richard-Allan Medical Ind., Inc. | 1986-06-17 |
| K862141 | HISTOLOGY PARAFFIN | Erie Scientific Co. | 1986-06-13 |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Surgipath Medical Industries, Inc. | 1986-04-11 |
| K842053 | PARAPLAST EXTRA TISSUE EMBEDDING MED. | Sherwood Medical Co. | 1984-06-26 |
| K833071 | TECHNICON PARACUT | Technicon Instruments Corp. | 1983-10-14 |
| K831580 | PARAFFIN INFILTRATION MEDIUM | Surgipath Medical Industries, Inc. | 1983-06-17 |
| K812191 | VASPAR SEALENT | American Scientific Products | 1981-08-31 |
| K810568 | PARAFFIN EMBEDDING MEDIUM | Surgipath Medical Industries, Inc. | 1981-03-17 |
| K803241 | HISTOLOGICAL EMBEDDING MEDIA | Miles Laboratories, Inc. | 1981-01-28 |
| K760602 | SORVALL EMBEDDING MEDIUM | E.I. Dupont DE Nemours & Co., Inc. | 1976-09-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10849832000973 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-02-03 |
| 00849832021667 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-02-03 |
| 10849832021664 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-02-03 |
| 00849832000976 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-02-03 |
| 10849832012525 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 10849832012532 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 10849832020476 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 00849832020479 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 00849832012535 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 00849832012528 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 00849832012573 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832012566 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832012542 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832000969 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832000945 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832000938 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832021643 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832021640 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832021626 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832000942 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832012570 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832012563 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832012549 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 10849832000966 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-18 |
| 00849832021421 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 00849832021438 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 10849832021435 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 10849832021428 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 00615233081728 | Tissue-Tek Xpress® x50 | SAKURA FINETEK U.S.A., INC. | 2019-12-15 |
| 00615233081667 | Tissue-Tek Xpress® x120 | SAKURA FINETEK U.S.A., INC. | 2019-12-15 |