Aniline
Aniline is an aromatic amine used as a component in multiple histological staining solutions and dye formulations, including aniline blue in trichrome stains, where it contributes to the coloration of collagen and mucin in tissue sections. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is ICX, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
Research product code ICX 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
- ICX
- 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 |
|---|---|---|---|---|
| K972867 | CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT | Oct 24, 1997 | Substantially Equivalent | Rocket Medical Plc |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.