Product code HYJ
- Device name
- Hematoxylin
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- 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 |
|---|---|---|---|
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Anatech, Ltd. | 1987-07-09 |
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Anatech, Ltd. | 1987-07-09 |
| K842740 | DELAFIELD HEMATOXYLIN STAIN | E K Ind., Inc. | 1984-08-17 |
| K842741 | GILL HEMATOXYLIN STAIN | E K Ind., Inc. | 1984-08-15 |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Accra Laboratories, Inc. | 1983-06-08 |
| K822352 | HEMATOXYLIN STAIN SOLUTION | Fisher Scientific Co., LLC | 1982-08-16 |
| K821533 | HEMATOXYLIN I | Volu Sol Medical Industries | 1982-06-10 |
| K821540 | HEMATOXYLIN II | Volu Sol Medical Industries | 1982-06-10 |
| K821541 | HEMATOXYLIN III | Volu Sol Medical Industries | 1982-06-10 |
| K821320 | HEMATOXYLIN STAIN | Sigma Chemical Co. | 1982-06-02 |
| K821062 | HEMATOXYLIN SOLUTION | Sigma Chemical Co. | 1982-04-29 |
| K811802 | HEMATOXYLIN | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| K810758 | GILL'S HEMATOXYLIN #1 | Surgipath | 1981-04-14 |
| K810759 | GILL'S HEMATOXYLIN #2 | Surgipath | 1981-04-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04015630972135 | Hematoxylin II | Ventana Medical Systems, Inc. | 2025-12-15 |
| B502BSB0360500 | Pink Hematoxylin Counterstainer | BIO SB, INC. | 2025-03-18 |
| B502BSB03602000 | Pink Hematoxylin Counterstainer | BIO SB, INC. | 2025-03-18 |
| B502BSB0360150 | Pink Hematoxylin Counterstainer | BIO SB, INC. | 2025-03-18 |
| B502BSB036010000 | Pink Hematoxylin Counterstainer | BIO SB, INC. | 2025-03-18 |
| B502BSB03601000 | Pink Hematoxylin Counterstainer | BIO SB, INC. | 2025-03-18 |
| 08435804516624 | Contrast Hematolxylin HDH3 | VITRO SA | 2025-02-20 |
| 08435421273498 | Contrast Hematolxylin HDH3 | VITRO SA | 2025-02-20 |
| 00849832027171 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-20 |
| 00849832027041 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-19 |
| 20849832018081 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-16 |
| 00849832018087 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-16 |
| 10849832023064 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-16 |
| 00000000000000 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-16 |
| 00849832018049 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 00849832020783 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 00849832022817 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-15 |
| 00673693089609 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693087926 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087940 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087964 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693089807 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 06973471960644 | BioSci™ | Shenzhen Dakewe Bio-engineering Co., Ltd | 2023-09-12 |
| 00847627014504 | Tacha's Automated Hematoxylin | BIOCARE MEDICAL LLC | 2022-12-13 |
| 00613647023204 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647023174 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647023143 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647023136 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647023129 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647023112 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |