LBA — Procainamide Control Materials Class I
FDA product code LBA covers "Procainamide Control Materials", a Class I medical device regulated under 21 CFR 862.3280. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LBA
- Device Class
- Class I
- Regulation Number
- 862.3280
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K833227 | sonicaid | SONICAID MODEL D206E AIR EMBOLI-DETECT | October 27, 1983 |