510(k) K041712 ยท DIS Enzyme Immunoassay, Barbiturate
'RAPIDTEC 4' TEST
| Applicant | American Bio Medica Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Nov 3, 2004 |
| Received | Jun 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041712
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.