Hematoxylin
Hematoxylin is a naturally derived histological staining reagent used as the principal nuclear dye in the widely employed hematoxylin and eosin (H&E) stain, binding to nucleic acids and imparting a blue-purple color to cell nuclei in tissue sections for diagnostic pathology. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYJ falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HYJ
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Jul 09, 1987 | Substantially Equivalent | Anatech, Ltd. |
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Jul 09, 1987 | Substantially Equivalent | Anatech, Ltd. |
| K842740 | DELAFIELD HEMATOXYLIN STAIN | Aug 17, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842741 | GILL HEMATOXYLIN STAIN | Aug 15, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Jun 08, 1983 | Substantially Equivalent | Accra Laboratories, Inc. |
| K822352 | HEMATOXYLIN STAIN SOLUTION | Aug 16, 1982 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K821541 | HEMATOXYLIN III | Jun 10, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K821540 | HEMATOXYLIN II | Jun 10, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K821533 | HEMATOXYLIN I | Jun 10, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K821320 | HEMATOXYLIN STAIN | Jun 02, 1982 | Substantially Equivalent | Sigma Chemical Co. |
| K821062 | HEMATOXYLIN SOLUTION | Apr 29, 1982 | Substantially Equivalent | Sigma Chemical Co. |
| K811802 | HEMATOXYLIN | Jul 28, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K810759 | GILL'S HEMATOXYLIN #2 | Apr 14, 1981 | Substantially Equivalent | Surgipath |
| K810758 | GILL'S HEMATOXYLIN #1 | Apr 14, 1981 | Substantially Equivalent | Surgipath |
FEI Numbers
This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.