Orange G
Orange G is an acidic azo dye used in histological staining procedures, commonly as a component of the Papanicolaou staining method where it stains keratin and erythrocytes orange-yellow. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is HZH, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- HZH
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842924 | ORANGE G, 1% | Sep 07, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K822038 | VOLU-SOL ORANGE G-6(GILLS-MOD | Aug 03, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K811825 | ORANGE G-6 | Jul 10, 1981 | Substantially Equivalent | Surgipath |
| K800323 | VOLU-SOL ORANGE G-6 STAIN | Feb 22, 1980 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.