Hematoxylin Harris'S
Harris's hematoxylin is a formulation of hematoxylin prepared using mercuric oxide as a mordant, producing a regressive staining solution widely used for nuclear staining in routine histopathology including gynecological cytology preparations. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYK falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HYK
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K873107 | INSTANT HEMATOXYLIN | Aug 21, 1987 | Substantially Equivalent | Shandon, Inc. |
| K872498 | HARRIS HEMATOXYLIN | Jul 09, 1987 | Substantially Equivalent | Anatech, Ltd. |
| K843425 | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | Oct 02, 1984 | Substantially Equivalent | Accra Laboratories, Inc. |
| K823328 | HARRIS HEMATOXYLIN | Dec 28, 1982 | Substantially Equivalent | Accra Laboratories, Inc. |
| K810733 | HARRIS HEMATOXYLIN | Apr 14, 1981 | Substantially Equivalent | Surgipath |
| K800324 | VOLU-SOL HARRIS HEMATOXYLIN | Feb 22, 1980 | Substantially Equivalent | Volu Sol Medical Industries |
| K781585 | HEMATOXYLIN STAIN HARRIS | Oct 10, 1978 | Substantially Equivalent | Bioscientific |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.