510(k) K890002 ยท KLS Enzyme Immunoassay, Theophylline
COAT-A-COUNT (TM) THEOPHYLLINE
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jan 23, 1989 |
| Received | Jan 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890002
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.