LGY — Trypan Blue Class I
FDA product code LGY covers "Trypan Blue", 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
- LGY
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K810782 | dutchland laboratories | TRYPAN BLUE (0.5% IN NORMAL SALINE) | May 13, 1981 |