Stains, Dye Solution
Dye solution stains are laboratory reagents consisting of dissolved dyes used to color cellular structures in hematology and histology preparations, allowing differentiation of cell nuclei, cytoplasm, and other components for microscopic diagnosis. They are classified as FDA Class 1 and are exempt from GMP requirements, indicating very low risk. The product code is LEE, regulated under 21 CFR 864.1850, in the Hematology specialty. No premarket notification is required.
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Basic Information
- Product Code
- LEE
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823363 | COUNT-10 STAIN | Dec 15, 1982 | Substantially Equivalent | V-Tech, Inc. |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.