KJY — Malachite Green Class I
FDA product code KJY covers "Malachite Green", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification details
- Product Code
- KJY
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- 510(k) Exempt
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K864033 | Sigma Diagnostics | RAPID ACID FAST STAIN | Nov 13, 1986 |