Erythrosin B
Erythrosin B is a synthetic fluorescent dye used as a histological staining reagent in hematology laboratory settings, applied to highlight cellular and tissue structures in microscopic examination. It is classified as FDA Class 1, indicating it poses low risk and is subject only to general controls without requiring premarket clearance or approval. The product code is KJR and it falls under 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.
Research product code KJR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KJR
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842834 | HEP-2 CELLS | Aug 28, 1984 | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. |
| K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS | Aug 28, 1984 | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. |
| K792546 | FETAL CHECK | Dec 18, 1979 | Substantially Equivalent | Alta Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.