Fast Red Salt B
Fast Red Salt B is a chemical reagent used in histochemical staining procedures to detect enzyme activity or specific tissue components by forming a colored azo dye upon reaction with tissue substrates in diagnostic pathology. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYD falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HYD
- 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 |
|---|---|---|---|---|
| K792549 | FAT RED 7B STAIN SET | Dec 18, 1979 | Substantially Equivalent | Electrophoresis Corp. of America |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.