Panels › Clinical Toxicology › Product code LCA · Class 2
Radioimmunoassay, Theophylline
Regulation 862.3880
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LCA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioclinical Corp. | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Medical & Scientific Designs, Inc. | 1 | 0 |
| Photec Diagnostics, Inc. | 1 | 0 |
| Ria Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 1988 | K880291 | THEOPHYLLINE TEST KIT REF. #A874799 Photec Diagnostics, Inc. | LCA |
| Jan 24, 1984 | K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY Medical & Scientific Designs, Inc. | LCA |
| Jul 6, 1982 | K821862 | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. Kallestad Laboratories, Inc. | LCA |
| May 28, 1982 | K821347 | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. Bioclinical Corp. | LCA |
| Feb 25, 1980 | K792062 | THEOPHYLLINE RIASSAY Ria Diagnostics | LCA |
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