510(k) K003647 ยท DIS Enzyme Immunoassay, Barbiturate
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
| Applicant | Alfa Scientific Designs, Inc., Poway CA, US |
| Decision | Substantially Equivalent, May 29, 2001 |
| Received | Nov 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003647
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.