510(k) K821544 ยท KLS Enzyme Immunoassay, Theophylline
DETECTION OF THEOPHYLLINE
| Applicant | Electro-Nucleonics Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 10, 1982 |
| Received | May 24, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821544
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.