LCAClass II
Radioimmunoassay, Theophylline
21 CFR 862.3880 / Clinical Toxicology
LCA is the FDA product code for Radioimmunoassay, Theophylline, a class II device type, regulated under 21 CFR 862.3880. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- LCA
- Device name
- Radioimmunoassay, Theophylline
- Regulation
- 21 CFR 862.3880
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code LCA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 2 |
| 1984 | 1 |
| 1988 | 1 |
Applicants with the most clearances
Product code LCA| Applicant | Clearances |
|---|---|
| Bioclinical Corp. | 1 |
| Kallestad Laboratories, Inc. | 1 |
| Medical & Scientific Designs, Inc. | 1 |
| Photec Diagnostics, Inc. | 1 |
| Ria Diagnostics | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code LCA.
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