LCI — Automated Radioimmunoassay Systems, For Clinical Use Class I
FDA product code LCI covers "Automated Radioimmunoassay Systems, For Clinical Use", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LCI
- Device Class
- Class I
- Regulation Number
- 862.2050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No