LCA
5 FDA 510(k) clearances · Product code
59 daysmedian time to decision
133 days90th percentile
5clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THEOPHYLLINE TEST KIT REF. #A874799 (K880291) | Photec Diagnostics, Inc. | 1988-03-24 |
| PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (K833789) | Medical & Scientific Designs, Inc. | 1984-01-24 |
| QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. (K821862) | Kallestad Laboratories, Inc. | 1982-07-06 |
| BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (K821347) | Bioclinical Corp. | 1982-05-28 |
| THEOPHYLLINE RIASSAY (K792062) | Ria Diagnostics | 1980-02-25 |
Track LCA automatically
Every clearance here is in the API, with alerts when new ones post.