510(k) K070009 ยท DIS Enzyme Immunoassay, Barbiturate
AT HOME DRUG TEST MODELS, 9308T AND 9308X
| Applicant | Phamatech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Jan 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070009
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.