510(k) K000522 ยท DIS Enzyme Immunoassay, Barbiturate
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
| Applicant | Drug Detection Devices, Ltd., Alpharetta GA, US |
| Decision | Substantially Equivalent, Apr 18, 2000 |
| Received | Feb 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000522
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.