510(k) K011771 ยท KLS Enzyme Immunoassay, Theophylline
RANDOX THEOPHYLLINE
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jan 17, 2002 |
| Received | Jun 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011771
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.