DOA — Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. Class II
FDA product code DOA covers "Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.", a Class II medical device regulated under 21 CFR 862.3320. 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
- DOA
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K032291 | linde medical sensors | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | August 24, 2004 |