Eosin Y
Eosin Y is a synthetic red dye used as a histological staining reagent to provide contrast to cell cytoplasm and other tissue structures in tissue sections examined under a microscope, commonly paired with hematoxylin in the H&E staining protocol. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYB falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HYB
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893663 | INSTANT EOSIN-AQUEOUS | Jun 13, 1989 | Substantially Equivalent | Shandon, Inc. |
| K880596 | EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE | Mar 31, 1988 | Substantially Equivalent | Sigma Chemical Co. |
| K880240 | INSTANT EOSIN-ALCOHOLIC | Mar 03, 1988 | Substantially Equivalent | Shandon, Inc. |
| K843426 | EOSIN Y 1% ALCOHOLIC | Sep 27, 1984 | Substantially Equivalent | Accra Laboratories, Inc. |
| K822982 | MIDAS 100 HEMACOLOR STAIN #66030 | Oct 27, 1982 | Substantially Equivalent | Emd Chemicals, Inc. |
| K821574 | EOSIN Y SOLUTIN, AGUEOUS | Jun 10, 1982 | Substantially Equivalent | Sigma Chemical Co. |
| K821573 | EOSIN Y SOLUTION ALCHOLIC | Jun 09, 1982 | Substantially Equivalent | Sigma Chemical Co. |
| K811797 | EOSIN-Y | Jul 28, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K811826 | EOSIN Y | Jul 10, 1981 | Substantially Equivalent | Surgipath |
| K800942 | VOLU-SOL EOSIN Y STAIN | May 08, 1980 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.