Stains, Dye Powder
Dye powder stains are hematology and histology laboratory reagents in dry powder form that are dissolved before use to prepare staining solutions for differentiating cell types and tissue components under the microscope. They are classified as FDA Class 1, the lowest risk tier, and are exempt from Good Manufacturing Practice (GMP) requirements. The product code is LEF, regulated under 21 CFR 864.1850, in the Hematology specialty. No premarket notification is required.
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Basic Information
- Product Code
- LEF
- 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 |
|---|---|---|---|---|
| K871476 | SILVER STAIN REAGENT SYSTEM | May 21, 1987 | Substantially Equivalent | Sigma Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.