LTB — Cyclosporine Radioimmunoassay Class II
FDA product code LTB covers "Cyclosporine Radioimmunoassay", a Class II medical device regulated under 21 CFR 862.1235. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LTB
- Device Class
- Class II
- Regulation Number
- 862.1235
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K813523 | techhnilab instruments | ELECTRIC SELF STERILIZATION INOCUL. LOOP | December 31, 1981 |