510(k) K821154 ยท KLS Enzyme Immunoassay, Theophylline
KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME
| Applicant | Jay Rau, Technical Suppprt, Mchenry IL, US |
| Decision | Substantially Equivalent, May 13, 1982 |
| Received | Apr 26, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821154
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.