LCA — Radioimmunoassay, Theophylline Class II
FDA Device Classification
Classification Details
- Product Code
- LCA
- Device Class
- Class II
- Regulation Number
- 862.3880
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K880291 | photec diagnostics | THEOPHYLLINE TEST KIT REF. #A874799 | March 24, 1988 |
| K833789 | medical and scientific designs | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | January 24, 1984 |
| K821862 | kallestad laboratories | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. | July 6, 1982 |
| K821347 | bioclinical | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. | May 28, 1982 |
| K792062 | ria diagnostics | THEOPHYLLINE RIASSAY | February 25, 1980 |