510(k) K980153 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DRUG CHECK
| Applicant | Texas Immunology, Inc., Tyler TX, US |
| Decision | Substantially Equivalent, Mar 27, 1998 |
| Received | Jan 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980153
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.