510(k) K053359 ยท DKZ Enzyme Immunoassay, Amphetamine
RAPIDTOX
| Applicant | American Bio Medica Corp., Beverly MA, US |
| Decision | Substantially Equivalent, May 25, 2006 |
| Received | Dec 2, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053359
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.