Product code LDZ
- Device name
- Fixative, Alcohol 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 |
|---|---|---|---|
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | 1988-08-17 |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | Surgipath Medical Industries, Inc. | 1988-05-25 |
| K881698 | ATS PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | 1988-05-13 |
| K862725 | SACCOMANNO SPECIMAN SOLUTION | Mill-Rose Laboratory | 1986-08-01 |
| K843428 | BIOFIX | Accra Laboratories, Inc. | 1984-09-27 |
| K842913 | WRIGHT STAIN FIXATIVE | E K Ind., Inc. | 1984-09-07 |
| K831061 | PVA FIXATIVE/FORMALIN | American Micro Scan | 1983-06-08 |
| K761138 | FA TISSUE FIXATIVE & WASH SET | Zeus Scientific, Inc. | 1978-01-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00673693181723 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-11-19 |
| 00673693228299 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693085465 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693556729 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00673693755146 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-24 |
| 00860011780571 | Chemical Service Labs, LLC | Protean Resources, LLC. | 2024-03-18 |
| 00860011780588 | Chemical Service Labs, LLC | Protean Resources, LLC. | 2024-03-18 |
| 00380740129590 | Alinity | Abbott GmbH | 2023-11-16 |
| M84941012 | Hobbs Medical Saccomanno Cell Transport System | HOBBS MEDICAL, INC. | 2023-06-12 |
| M84941010 | Hobbs Medical Saccomanno Cell Transport System | HOBBS MEDICAL, INC. | 2023-06-12 |
| 00810047420965 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420958 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420941 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420934 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420569 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420552 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420545 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00816085021386 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085022369 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085022352 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085022338 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085022178 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021348 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021331 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021324 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085020570 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021355 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085022314 | PVA (Zn) Fix/10% Formalin 25 sets | Alpha-TEC Systems, Inc. | 2022-07-20 |
| 00615233081568 | Tissue-Tek Xpress® | SAKURA FINETEK U.S.A., INC. | 2019-12-15 |
| 00382904907198 | BD CytoRichâ„¢ Clear Preservative | BECTON, DICKINSON AND COMPANY | 2019-07-02 |